Pluripotent therapeutic compositions and uses thereof

ABSTRACT

Synthetic Stem Cell-like Tissue Healing and Regeneration Medication with Anti-inflammatory, Protein Synthesis, Enzyme Deficiency Activation and Genetic Therapy, and Anti-cancer Agent derived from a series of inventions that include these products of Biomolecular Engineering, Drug Discovery from a Biologic Periodic Table of Applied Biochemistry and Biophysics. Tissue has a self healing effect promoting tissue healing and tissue regeneration. Not only does it maintain good health but also it has been observed that the patient&#39;s blood is withdrawn from the patient and applied to the ulcer has healing qualities. Cartilage placed in a wound promotes and accelerates wound healing. The anabolic biochemical and biophysical equivalent of tissue has been found in these embodiments to have the same pharmacologic qualities, when devoid of genetic DNA mismatch and other catabolic factors including the catabolic effects of microorganism overgrowth that lacks pro-biotic qualities. The healing efficacy of these tissue components gives us further appreciation of the protective action of human tissue over and above and other than the immune protective system or perhaps an integral component part of the immune system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.10/868,697, filed Jun. 14, 2004, which claims the benefit of U.S.Provisional Patent Application Ser. Nos. 60/577,120, filed tune 4, 2004;60/557,584; filed Mar. 29, 2004; 60/550,797, filed Mar. 5, 2004;60/478,565, filed Jun. 12, 2003; 60/493,237, filed Aug. 6, 2003; and60/523,936, filed Nov. 21, 2003. These applications are all herebyincorporated by reference in their entireties, including all figures,formulae, references, amino acid and nucleic acid sequences, and tables.

This application is a continuation-in-part of U.S. application Ser. No.10/868,697, filed Jun. 14, 2004, which is a continuation-in-part ofapplication Ser. No. 10/765,664, filed Jan. 26, 2004 which claims thebenefit of U.S. Provisional Patent Application Ser. Nos. 60/442,278,filed Jan. 24, 2003; 60/447,779, filed Feb. 13, 2003; 60/448,003, filedFeb. 18, 2003; 60/448,497, filed Feb. 19, 2003; 60/478,565, filed Jun.12, 2003; 60/493,237, filed Aug. 6, 2003; and 60/523,936, filed Nov. 21,2003. These applications are all hereby incorporated by reference intheir entireties, including all figures, formulae, references, aminoacid and nucleic acid sequences, and tables.

This application is a continuation-in-part of U.S. application Ser. No.10/868,697, filed Jun. 14, 2004, which is also a continuation-in-part ofapplication of U.S. application Ser. No. 10/752,298, filed Jan. 5, 2004,which claims the benefit of 60/437,939, filed Jan. 3, 2003. Theseapplications are all hereby incorporated by reference in theirentireties, including all figures, formulae, references, amino acid andnucleic acid sequences, and tables.

This application is a continuation-in-part of U.S. application Ser. No.10/868,697, filed Jun. 14, 2004, which is also a continuation-in-part ofU.S. application Ser. No. 09/639,859, filed Aug. 16, 2000 (now U.S. Pat.No. 6,974,796), which claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/149,338, filed Aug. 17, 1999. These applicationsare all hereby incorporated by reference in their entireties, includingall figures, formulae, references, amino acid and nucleic acidsequences, and tables.

This application is also a continuation-in-part of U.S. Application Ser.No. 11/501,380, filed Aug. 9, 2006, which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/707,571, filed Aug. 12, 2005.These applications are all hereby incorporated by reference in theirentireties, including all figures, formulae, references, amino acid andnucleic acid sequences, and tables.

BRIEF DESCRIPTION OF THE DRAWINGS

The composition that mimics human tissue and its impact on normalizationof diseased tissue.

1. Normalization of Cell Cycle.

FIGS. 1A-C. Expands upon the reversed hexagonal liquid crystalline phaselipophilic micelle of FIG. 2B with an HLB of less than 6 versusintermediate HLB of 8-10 with bilayer lamellar liquid crystalline phasegeometric configured micelle. Further to this comparison is anotherliquid crystalline phase hydrophilic micelle with the hexagonal micelleof hydrophilic HLB of more than 13. Other contrasted features include,in addition to the foregoing geometry of liquid crystalline phaseaggregation and the type of liquid crystalline phase aggregation,macroscopic character, HLB range, and surfactant parameters used in invitro embodiments with an 76% to 83% anticancer efficacy after 24 to 48hours of contacting these compositions with cancer cells. A)Lysophospholipids (e.g., oleic acid, stearic acid) showingmiscelles;—small spherical aggregates, clear solution; B) Double-chainedlipids with large head group areas (anionic lipids and saturated chains,(e.g., phosphatidylcholine, phosphatidylserine) and double-chainedlipids with small head group areas (anionic lipids and saturated chains,e.g., phosphatidylethanolamine, phosphatidylserine+Ca²⁺) showingbilayer/lamellar phase, milky dispersion; C) Double-chained lipids withsmall head group areas (e.g., non-ionic lipids), showing reversedhexagonal phase and rods of water surrounded by emulsifier and showinglumps of emulsifier in equilibrium with surplus of water.

FIGS. 2A-B. A) Illustrates (by arrows) lipophilic low HLB surfactant,and its reversed hexagonal phase micelle geometric configuration analog,to the abnormal mitosis in cancer. The typical sequence of phase thatdevelops when a surfactant is mixed with water. Similar geometricappearance mechanism. 2A) Mitotic figure, cancer; 2B) Reversed hexagonalphase (also shown in 1C).

FIG. 3. Mitosis and its phases—showing Centrioles, Nucleolus andChromatin and phase similar to reversed hexagonal phase low HLB colloidmicelle (lipophilic=hydrophobic phase of surfactant effect). Geneticdistribution, also mobilization of membrane of cell, cell nuclei, andintranuclear phospholipids.

II. Normalization of Inflamed Tissue—Anti-Inflammatory and ImmuneModulatory Effect of Therapeutic Composition.

Normalization of protein thereby reducing histamine release at theallergic response.

FIGS. 4A-B. A) Indium 111 abnormal radiogram of ileal inflammation shownradiographically by permeability test tagged neutrophile with Indium 111for Crohns Disease; B) Normalized ileum 4 weeks after therapeuticsubject composition after subject therapheutic composition, in contrastto FIG. 4A.

FIG. 5. In vitro basophilic de granulation measure by histamine releasecomparing efficacy of treated cat dander in preventing histamine releasewith untreated cat dander when exposed to serum from cat allergicpatients. Further applications: the addition of liquid crystalformulation and its effect on the protein molecule was demonstrated inregard to the structure and folding of the macro-molecular proteinantigen thereby modifying its biologic function and 3D antibody fit.This liquid crystalline formulation of processing of antigen resulted ina decrease of histamine release and abnormal response of allergy waslessened. In this case, the liquid crystalline formulation treated catdander was compared with the untreated cat dander control, and whenincubated with the patient's basophils and serum, the amount ofhistamine release was measured and found to be significantly lessened.

This structural change associated with reduction of allergenicity andantigenicity was further documented by specific protein polypeptidestains. Similar achievements in reduction in allergenicity have beenmade with allergens such as peanut, documented by RAST and Elisastudies. The peanut allergen was reduced by 285 times less (measured inpicograms in contrast to the untreated controls). In the case of milk,no allergen was detectable in contrast to the untreated controls (thebiologic properties of taste were not only maintained, but enhanced).

FIG. 6. The prion protein. This model depicts NMR results for thestructure of most of PR^(Pc). The globular, a-helical region lies at theC-terminus. Most of the N-terminal region appears to be a disorderedrandom coil. It is believed that it is this portion of the molecule thatfolds to produce the increase in B sheet observed in PR^(Sc) andassociated diseases such as Alzheimer's disease, Parkinson's disease,mad cow disease and its human variant—transmissible spongiformencephalopathies (diseases associated with abnormal dysfunctionalmis-folded protein, such as prion protein).

FIG. 7. Table showing diseases associated with abnormal dysfunctionalmis-folded protein such as prion protein.

FIGS. 8A-C. Sequence of events involved in protein folding showing: A)primary sequence with black circles representing hydrophobic residues;B) collapse of the hydrophobic primary sequence to a compact structurecontaining minimal contacts resulting in secondary structure formation;and C) native formation, directed by obtaining a conformation with themaximum number of interchain hydrophobic contacts and by disulfide bondformation. Finally, the other forces, i.e. H-bonding, van der Waalsforces and electrostatic interactions stabilize the native structure.

FIGS. 9A-B. Tables showing: A) relative probabilities of amino acidresidue occurrence in different globular protein secondarystructures—the pathogenic effect of structural changes that may benormalized; and B) Chou-Fasman rules for prediction.

FIGS. 10A-D. Sequence of events involved in protein folding: The 4levels of protein structure: A) Primary structure; B) Secondarystructure; C) Tertiary structure; and D) Quarternary structure. Thissummary of the structural levels of protein uses the HBG molecule, atetramer of myoglobin-line chains (indicated in the bold parts of thefigures).

FIG. 11. Definitions of the pitch of a helix P₁ and the number ofrepeating units per turn, n. The rise along the helix axis per repeatingunit is d=p/n. If the twists at every carbon atom are the same, then thechain falls naturally into a helix. Such helix of repeating subunits canbe described by the number of units per turn of helix, n, and by thedistance traversed parallel to the helix axis per unit, d. The productof these is the pitch of the helix, p. For a polypeptide chain of fixeddimensions, both n and d are determined.

FIG. 12. Minimum contact distances for non-bonded atoms. Top figure isfrom normally accepted van der Waals radii. Figures in parentheses arethe absolute minimum values found by Ramachandran in small structures.Distances are in Å. This precision can be adapted in this liquid crystalmedication system in providing therapeutic response.

FIGS. 13A-C. Varieties of fibrous proteins. A) Alpha helix—The mostfamiliar of the fibrous proteins are probably the keratins, which formthe protective covering of all land vertebrates: skin, fur, hair, claws,nails, hooves, horns, scales, beaks and feathers. Equally widespread ifless visible are the actin and myosin of muscle tissue. Epidermin isanother skin component, and fibrinogen is the precursor of theblood-clotting mechanism. A second great class of proteins is the silksand insect fibers. A third class is the collagens of tendons and hides,which form connective ligaments within the body and give extra supportto the skin where needed; B) Anti-parallel beta pleated sheets—Theseproteins are built up from three main structures: the alpha helix, theantiparallel beta pleated sheet, and the triple helix. The keratins aremostly alpha helix, with feathers in birds and some of the stiffer partsin non-mammals being a complicated form beta sheet. Myosin, epidermin,and fibrinogen are also alpha helical. The silks are the best example ofthe beta sheets sheet, and collagens use a characteristic triple helix;C) Collagen triple helix—Wool fibers form perhaps the best example of analpha helical structure. They are flexible, and are extensible over along range, up to twice their normal length. Yet they are elastic; whenthe tension is released, the fibers snap back again. It is just theseproperties that are responsible for the springiness and live feel ofgood wool cloth. On the other hand, the fibers are only moderatelystrong. The silk beta sheet structure is characterized by unusualstrength, great flexibility, but low extensibility. If tension isapplied to a silk fiber, rather than stretching, it resists elongationup to a point and then breaks. The collagen triple helix is quitestrong, resistant to stretching and so relatively rigid. These molecularconfigurations of folding determine the tissue properties.

FIG. 14. Amino acid content of three typical fibrous proteins expressedin mole % of amino acids. Principal components are marked with anasterisk. Silk fibroin, wood keratin and collagen.

FIG. 14A. Silks and the beta sheet. Silks are built from extendedpolypeptide chains stretched parallel to the fiber axis, withneighboring chains running in opposite directions and hydrogen-bonded toform a sheet as shown. Pauling and Corey, 1951, called it theantiparallel pleated sheet. The need to make good hydrogen bonds keepsthe chain from being fully extended. Hydrogen bonding within oneantiparallel beta sheet is shown. Unterminated dotted lines are hydrogenbonds to neighboring strands in the sheet.

FIG. 15. Chemical sequence studies of digested silk have shown thatbasic six-residue unit repeats for long distances in the chain:(Gly-Ser-Gly-Ala-Gly-Ala). The result is a fiber that is very strongbecause the resistance to tension is borne directly by the covalentbonds of the polypeptide chain. It is not appreciably extensible, forthe chain is already stretched as far as it can go without breaking thehydrogen bonds that hold the sheet together. But since the sheetsthemselves are held together only by van der Waals' forces betweenunbonded side chains, silk is quite flexible. The beta sheet is pleatedor rippled, with alternate side chains extending out on either side.Dashed lines indicate hydrogen bonds.

FIG. 16. The three dimensional architecture of silk. The side chains ofone sheet nestle quite efficiently between those of neighboring sheets.The cut bonds extend to neighboring chains in the same sheet. There isno room in this regularity packed crystalline structure for bulky sidechains such as tyrosine.

FIG. 16A. The sheets of silk are packed with ala against ala and glyagainst gly. The spacing between sheets therefore alternate between 5.7Angstrom units (Å) and 3.5 (Å).

FIGS. 17A-C. Alpha ketatin and the molecular assemblage of hair keratin.A) Alpha helix; B) Protofibril; C) Microfibril. The first thoroughlystudied alpha protein was the alpha keratin of wool. This commodity, ofgreat commercial importance, prompted this analysis. The basic unit ofhair keratin is an alpha helix, in about the same sense that the basicunit of a tapestry is a thread.

The weakest link is the gap between the x-ray and electron microscopeevidence. The smallest features that can be seen in the best micrographsare tiny “protofibrils”, 20 Å in diameter, running the length of thehair. The x-ray diffraction pattern shows that alpha helices must bepresent, yet these small protofibrils are too large to be alpha helices.

BACKGROUND OF INVENTION

In prior art, the treatment of disease centers around the position to“kill” as if we are trying to kill an infectious agent. This isexemplified by the discovery that platinum kills bacteria. Many of theleading cancer products of prior art are derivatives of platinum (orsimilar toxic products derive from the periodic table) such as but notlimited to cis-platinum and carbo platinum.

It would be desirable to surmount the awesome challenges of diseasetreatment by restructuring diseased tissue with biochemical andbiophysical components of normal tissue, which have the associatedfeatures of restructuring, healing and regeneration of organs and tissueto their normal status. This series of inventions mimic, in analogfashion, human tissue and thereby draws from normal molecular structuredbiochemicals with required biophysical function and from pharmacopoeiafrom major industrialized countries.

This has been so accomplished with results which include a therapeuticstem cell like composition which by simulating, accelerating andfacilitating stem cell healing increases the tissue regenerationcapacity of the patient's stem cells, thereby reversing diseases ofgreat severity and complication. For example, organ failure can bereversed without resorting to such extreme measures of desperation andgravity, including organ transplant or tissue graft. As result of thisunique focus and sourcing the associated risks and objections ofdependency upon the use of human tissue and human embryonic tissue isnot required.

This inventor has observed that tissue has a self healing effectpromoting tissue healing and tissue regeneration. Not only does itmaintain good health but also it has been observed that the patient'sblood is withdrawn from patients with a leg ulcer and the blood is thenapplied to the ulcer the blood is shown to have healing qualities.Cartilage placed in a wound also promotes and accelerates wound healing,exemplifying the function of Component No. 3. The anabolic biochemicaland biophysical essence and equivalence of tissue has been found inthese embodiments to have the same healing and tissue regenerationpharmacologic qualities, when devoid of genetic DNA mismatch and othercatabolic factors including the catabolic effects of microorganismovergrowth that lacks pro-biotic qualities. The healing efficacy ofthese tissue components gives us further appreciation of the protectiveaction of human tissue over and above (and other than) the immuneprotective system or perhaps an integral component of the immune system.

The components are most effective when freely available to the metabolicstream and thereby overcome the disease producing debris of disease andcrystal seeding effect obstructive and foreign to the metabolic stream.Mismatching is further assured by adherence to tissue equilibriumparticularly applied here the hydrophilic/lipophilic balance HLBequilibrium. Therapeutically, through polar surface active lipidsurfactants permits the tissue to maintain the unique required strata ofalternation of hydrophilic with hydrophobic components such as lipids.

This strata is analog to the earth's strata exemplified by thehydrophobic nucleus surrounded by hydrophobic cytoplasm furthersurrounded by lipophilic cell membrane and the strata is finalized witha hydrophilic extracellular matrix. The same patterned alternate stratacan be seen in the biomolecular macromolecules of proteins with thelipophilic central core derive primarily from the essential amino acidssurrounded by the hydrophilic periphery of primarily nonessential aminoacids further forming and attracting a clathrate cage of structuredordered nonrandom non-liquid water accounting for the alpha helix orbeta sheet folding and associated and dependent biologic structure andfunction.

It has been found in these embodiments that high HLB surfactanttreatment alters the allergenicity of cat protein's 3-D structure andpathogenicity.

These same biophysical features provide the opportunity to use highlyhydrophilic surfactants with their high surfactant packing parameters toprovide, through hydrogen bonding, a clathrate cage of structured waterand energy input and change in entropy that enhances refolding of themisfolded proteins and protein derangements and aggregates that arepathophysiologic and pathogenetic basis for diseases such as Alzheimer'sdisease, Parkinson's disease, Mad Cow disease and its human equivalenttransmissible spongiform encephalopathy. It is this tissue essence andthis biochemical and biophysical molecular engineering that has resultedin therapeutic efficacy combined with bio-safety offering therapeuticopportunities that have been otherwise not forthcoming.

The prior art teaches a passive relationship, between the genetic codeand amino acid structures. However, the prior art does not teach the useof therapeutic compositions for actively enhancing and normalizingfunctional aspects of the cell nucleus and cytoplasm in disease tostimulate, facilitate, and accelerate protein synthesis in diseasedorgans and tissues.

Therapeutic stimulant, activator and substrate compositions that providetherapy for hereditary diseases and conditions of hereditarypre-disposition were disclosed in provisional Patent Application Ser.No. 60/149,338, filed Aug. 17, 1999 and are described in co-pending,U.S. patent application Ser. No. 10/269,613, filed Oct. 11, 2002 (eachof which is hereby incorporated by reference in their entireties). Asthere disclosed, molecular monomers having alpha amino- and alphacarboxylic groupings similar in molar ratio of the component amino acidmonomers in human tissue and in accordance with the specific code of the20 amino acids of human tissue can be used for the treatment ofdiseases.

This unique drug discovery technology and characteristics of therapeuticsynthetic stem cell-like composition is unique to the prior art is ahealing tissue regenerative therapy and has been shown to be effectivein averting organ graft in the replacement of disease ravaged tissuewhether inflammatory, acute, chronically inflammatory, degenerative,neoplastic or genetic pathogenesis or etiologic on the basis ofmimicking and analog model of human and mammalian tissue. This anabolictissue copy basis is not only a biochemical copy, but also a functionalbio-physical model copy of normal tissue function, with meticulousavoidance of catabolic components, derived from a unique biologicperiodic table. The subject composition also permits reorganization asif the disease were analog to a “bankruptcy” major deficiency withreplenishment not only of the tissue, but even of its trace elements,vitamins and minerals. Additionally the diseased organ or tissuesecretions also represent a biochemical and biophysical copy fortherapeutic normalization of these secretions.

In producing these copies we have also copied the fluidity of functionby mimicking and preparing an analog copy and therefore normalizing thehydrophilic lipophilic (HLB) equilibrium balance, with HLB (withintramolecular OH₂/CH₂ ratio of these embodiments exemplified byintramolecular composition Tween 80) surfactant energy input andassociated change in entropy along with any defective human andmammalian tissue equilibria.

In so doing, not only the tissues, cells but even the microscopic andsub-microscopic structure and functions of the cell organelles undergonormalization of mitosis and apoptosis ideally characterized foranticancer therapy. The further normalization of mitosis includes themitotic organizing centers of centrioles, peri-centriolar clouds,spindles, chromosomes and centromeres (kinetochores) of the chromosomes,acting like seeds of crystallization in conjunction with themicrotubules and associated protein with tubulin tread millingpolymerization. The mitotic associated tubulin protein of themicrotubule has a double origin, the centriolar poles and thechromosome.

This nanogram and picogram pursuit of repair is all based on the atomicand molecular level of human tissue function as illustrated by ComponentNos. 1, 2, 3, 4, and 5 of the composition of the subject invention.

We find sequential to the foregoing a bio-computer signaling systembased on the semi-conductivity bio-computer inter-molecular, thereforeintercellular and inter-tissue signaling system of all components of No.1 and No. 2 and some components of No. 3. The functional biophysicaloverlapping of these three components is the polar surface active lipidsurfactant intrinsic to these foregoing components of an emulsifier theexpansion of biochemical surface area interaction by surfactant packingparameters and emulsion system, and most importantly thereby a controlof fluidity, metabolic fluidity, metabolism electrochemical chargebuildup and enhancement and signaling based on common semiconductor biocomputer functionality and obviating, correcting, avoiding crossroads ofdisease. ECM component No. 3 offers the proteoglycans complex aggregateto support the colloidal system with similar architectural structuralsupport of structured water, viscosity and lubricant effect of thesynovial membrane joints and vitreous helping to hold the respectiveretina and umbilical blood vessels in place and unobstructed analog tothe cell membrane phospholipids of component No. 2, with hyaluronidaseserving as a “colloidifier” analog to a high HLB emulsifier to adjust orreduce and “thin” viscosity to enhance flow.

This fluidizing effect converts roadblocks of disease such as crystalsof calcium, cholesterol, uric acid, pigment, disease debris andexogenous crystals such as, but not limited to, silica and asbestos, allacting as disease producing microscopic shards or ‘thorns’ sticking inthe metabolic throat and sides of the patient's tissue.

The anti-inflammatory effects associated with all three componentsanti-inflammatory bio physiologic activities and accompany proteinsynthesis of components one and two (such as lyso-lecithin proteinsynthesis stimulus effects of PC of component two) as but not limited tothe contrasting tetrahedral alpha amino acid non D, Levorotary aminoacids and non-chiral glycine with proteins tissue fits of these tissue20 specific to the genetic code amino acids in sharp contrast to thearomatic benzene ring derivatives that do not fit of otheranti-inflammatory drugs and therefore also interfere with proteinsynthesis. Medication side effects are less when co-used with subjectcomposition. Enhancement of enzymatic activity associated withsurfactant packing parameters and companion increase in vital zetapotential with use of high HLB surfactants.

The foregoing can be exemplified by non-intrusive, bio-safe,non-coalescent compositions comprise component No. 1,anabolic-non-dextrorotary (“non-D” L amino acids, including but notlimited to L-amino acids and non-chiral glycine); component No. 2 (oneor more cell membrane components formed by self-vesiculatingsurface-active polar lipids such as but not limited to phosphatidylcholine (PC) that forms the double layer of the mammalian cell andnuclear membranes), and component No. 3 (extracellular matrix materialsuch as collagen, proteoglycans, chondroitin sulfate, or mixturesthereof).

These therapeutic compositions are abundantly supplied and areformulated to contain amino acids in amounts that correspond to molarratio of amino acids in a damaged organ, tissue, or protein. The amountsof each component can be adjusted to match the nature of the organ ortissue being treated. In reversing disease through this series ofinventions, major side effects can be greatly minimized with co-use orsole use with these therapeutic compositions.

It is not only in the applied biochemistry and its associatedbiomolecular structures but also the biophysical surfactant functionsincluding surfactant packing parameters and particle charge of thesethree component compartments and particularly the key to this fluiddynamics fluidizing and hydrophilizing therapy (also present incomponents one and three with the most concentrated surfactant functionin two) can be poignantly modulated even with the challenge ofmodulating and thereby normalizing the abnormal mitosis of cancerthrough the biophysical function and structure of the polar surfaceactive lipids in component number two along with maturation factor ofethylene oxide Tween 80 component never two. The amount ofsurface-active polar lipid to include in the composition can bedetermined by viscosity measurements. Tissue concentration can bemeasured by viscosity (as used in blood serum which normally is 1.12 to1.22 centipoise with upper limit of three). In the case of theintermediate HLB 8 to 11 (as exemplified by PC phosphatidyl choline whenso used) circulation is improved 25% however there is no change inviscosity or the red blood cell sedimentation rate at these HLB rangesbecause of the fact that biophysical functional effects is upon the cellmembrane. With its use the red cell membrane becomes more plastic, andis made more pliable thereby enhancing circulation and oxygenation.

Providing a polar surface active lipid liquid crystal surfactant ofextreme HLB to overcome the disturbed fluid balance and lack of fluidityof the biophysical inertia of the non metabolizable necrotic debris ofthe disease process results in a crystal (such as but not limited tocalcium phosphate crystal where the phosphorylase enzyme which in turnreleases phosphate to produce the insoluble salt deposit of calciumphosphate).

MRI crystalline calcium salts detected by MRI in the coronary artery maymake stress testing not necessary. And biochemical models so derivedfrom the crystallization requirements (as historically in the case outof the x-ray diffraction study of the DNA molecule) may lead to thebiomolecular engineering model of life but the possibility of thedisease variant of life (in contrast to normal model of life) must begiven serious contrasting consideration.

Other intracellular and tissue body deposition responses include thelipid cholesterol crystal found in atherosclerosis and coronary arterydisease whereby the lipid crystal has a melting point of 50 degreeshigher than normal body temperature. Other solid crystal responsesincluded poorly soluble uric acid crystal deposits derived from purinemetabolic products or exogenous derived silica crystal and asbestosbodies and other difficult to process shards resistant to fluiditynecessary for normal metabolic processing. These perpetuating foreignsubstances promote chronic inflammation, chronic granulomatousreactions, and in certain situations (such as but not limited toasbestos) may progress to cancer after a long period of deposition(which may be as long as 20 years). In this debris may included poorlyattainable or derivable processing due to lack of metabolic tools (suchas but not limited to in the case of a carbohydrate and glycogen trappedas polymerized glucose form of energy not obtainable from glucosebecause of the lack of insulin receptor response as in the case of TypeII diabetes or deficiency of enzymes as in the case of “storagediseases”). In the case of trans fats, it has been observed to beassociated with Type II diabetes with poor insulin receptor responseeven though production of insulin is adequate. Hereto it is likely thattrans fat deposits, without adaptable trans fat enzymes, and again with40 to 50 degrees melting point higher than body temperature may beamenable to dispersement of the fat with low HLB surfactant followed byfurther fluidizing the fat with the high HLB surfactant.

Protein, when misfolded, loses its biologic function in diseases such asAlzheimer's disease, Huntington's disease, and Mad Cow disease withresulting neuropathologic response of tangles, which also may be seenwith lead poisoning and metals such as aluminum and zinc that are underconsideration for their involvement with Alzheimer's disease.

The extracellular matrix material of Component No. 3 can include, inaddition to collagen and elastin, cartilage derived from tracheal rings(of bovine or shark origin) and complex aggregates of very largemacromolecule straight chain amino polysaccharide hyaluronic acidpolymers of glucosamine and glucuronic acid covalently linked to(proteins and core proteins) and non-covalently linked to chondroitinsulfate.

The function of these extracellular matrix compounds includearchitectural integrity, imbibing of water as a biocolloid, serving as alubricated surface (as exemplified by the synovial membranes (andrationale for a therapeutic application in regard to arthritis) andmaintenance of viscosity analog to component number two the polarsurface active lipids such as but not limited to phosphatidylcholinewith an HLB of 10 to 11. Hyaluronidase has been looked upon in the bodyand therapeutically as a fluidizing, viscosity reducing, thinning enzymewith analog effect of high HLB (15 to 20) surfactants (such as but notlimited to Tween 80 and sodium lauryl sulfate).

A 48 percent inhibition of calcium oxalate urinary tract stone formationwas observed in a multi-center study of more than 120 patients givenglycoaminoglycans sulfated polysaccharide. The remaining patients formedstones that were smaller and more readily removable in regard to crystalcell adhesion. Similar effects with ECM on blood rheology was noted aswith extreme of HLB response with reduction of blood viscosity andlipids as well as anti-coagulant effects.

In other multi-center studies more than 100 patients showed significantimprovement in wound healing with a 48% increase in tensile strength ofhealed wound. Similar effects were noted in controlled animal studies.

Optional components for the compositions of the subject invention,include, but are not limited to, non-hydrolysate-derived milksubstitutes (free of catabolic products and D amino acids such asmicroorganism, derived sources). When used in patients with clinicallysuspected milk allergy or bronchial asthma respiratory tract allergy(such as nasal allergy and hay fever (documentation with allergy skintesting is usually nonproductive)), the patients respond to thistherapeutic composition, which may in terms of therapeutic rationale andmechanism response, most probably also reside in the anti-inflammatoryaction, immune modulatory effects completely free of side effects suchas commonly seen soporific effects of the antihistamines used forallergic rhinitis, or the side effects of antiasthmatic sympathomimeticsand corticosteroids. Also as stressed when used in conjunction withthese anti-asthmatic, anti-allergic medications side effects are greatlyminimized. This is exemplified by the avoidance of common soporific sideeffects seen with antihistaminics. As with all these therapeuticapplications, their co-use with medications lessens the dosage and theassociated side effects.

Catabolic products are avoided or absent from the compositions,especially chiral amino acids and racemic mixtures containing aminoacids in D form, as well as, e.g. cyclosporin oligopeptides andbacterial cellular walls. More severe complications of allergic andhypersensitivity diseases may include autoimmune disease such as lupuserythematosis and medication reaction induced false lupus. False lupushas responded to these therapeutic compositions including the collagenproteoglycan aggregate cartilage, chondroitin sulfate complex, therebyavoiding the risks of cortico-steroids, commonly required in thesepatients, particularly in those patients with the complication ofpericardial infusion.

The compositions can also optionally incorporate material that includesstem cells or materials derived from after-birth tissue such as placentaand umbilical cord. The compositions can also include materials thatcorrespond in amino acid composition to mother's milk or to othermaterials encountered during fetal and infantile development.

The compositions of the invention also mimic mother's milk or embryonaltissue. This embryonal tissue simultaneously mimics healing tissue,associated with such diseases as inflammation and tissue damage such astrauma, at the same time mimicking and being analogous to mammalian andparticularly the human stem cell.

In addition, vitamin D supplied in this therapeutic stem cell subjectcomposition and the case in toxic heavy metals would drive and sequesterthese heavy metals such as not limited to lead into the bones by theirchelating; effects thereby greatly minimizing their neurologic toxiceffects.

Additionally, vitamin D can optionally be added to further direct thisenzyme therapy to the bone marrow involved in lysosomal storage diseaseencroachment on the bone marrow.

If therapeutic replacement enzymes are not available, high HLBsurfactant such as but not limited to Tween 80 or sodium lauryl sulfate0.125% to 1% or 10% to 50% of the LD 50 in normal animals with normalHLBs.

In this therapeutic composition can further comprise phosphatidylcholine(PC), commonly derived from the soybean plant by degumming followed byacetone extraction. The highest concentrations of PC are present atbirth during youth and young adult phases of life and then decreasesprogressively until old age. Premature infants are particularly prone toatelectasis or lung collapse, respiratory distress syndrome of thenewborn and may be contrasted with full term infants that have adequatePC levels. The sudden rise in saturated PC at 34 to 36 weeks ofgestation marks the development of fetal lung maturity. Thephospholipids produced represent most of the lipid produced the majorityof which is lecithin-saturated PC up to 85 percent of the lecithin, 60percent of the lecithin is dipalmitoyl PC. Other lipids present arephosphatidylglycerol (PG), phosphatidylinositol (PI),phosphatidylethanolamine (PE).

Plant hormones, such as but not limited to, ethylene, abscisic acid(ABA), and gibberelic acid (GA3), a gibberelin, zeatin a (cytokine),auxins (indole-3 acetic acid, IAA) involved in chemiosmotic protongradients, Zeatin (a cytokine) may be offered in the subjectcompositions for the prevention or reduction of premature births. Theplant hormones may be added to highly hydrophilic surfactants in themodulation of mitosis adding to the management of cancer, and may beincorporated in therapeutic stem cell-like subject compositions, allwith a high degree of bio-safety. This is also emphasized relating toother embodiments concerning modulation of mitosis.

Variants of Tween 80, a highly ethoxylated high HLB hydrophilicsurfactant with 20 moles of ethylene oxide, can be ethoxylated furtherwith 20-40 or more moles of ethylene oxide to increase the HLB.Obversely Myrj represents a low HLB surfactant with 8 moles of ethyleneoxide moles to 1 mole of fatty acid such as stearic acid. Two carbonethylene, (and multiplicity of ethylene oxide derived surfactants),function as a maturation factor, and may be combined with hydrophilicsurfactant activity in these ethoxylated surfactants.

The compositions can be employed for local and systemic therapies andcan be delivered by topical, oral, parenteral or intravenous routes. Inthe case of cancer, intralesional or even intra-arteriallyadministration may be practiced. A more preferred route is oraladministration, preferably by oral mucosal delivery in which thecompositions are formulated into a lozenge or gum that is brought intocontact with the oral buccal sublingual, or pharyngeal mucosal surfacefor a few to twenty minutes (or longer) until absorbed. The high HLBmediated oral mucosal delivery system is as efficacious as parenteraladministration of such medications and prophylactic agents as vaccines(further documented by laboratory measured response in otherembodiments). When an oral route of administration is used, thecomponent concentrations can be lower than in intravenous routes, sincethe components do not pass through the liver. This oral mucosal deliverysystem can also be advantageously used with enzymes or hormonesadministration. The therapeutic compositions are preferably administeredat a temperature slightly less than 100 degrees F., more preferably ator about 98.6 degrees F., to further enhance the synergism of,surfactant and enzymatic activity.

The compositions offer protective effect including but not limited tothe chelating protective effect of the macromolecules such as, but notlimited to, DNA and their protection from toxic chemicals such as heavymetals as well as antioxidant protection from radiation. The exemplaryantioxidants for optional addition to the subject compositions include,but are not limited to vitamin A in the form of beta-carotene, 10,000units per day; D-alpha tocopherol 400 units ideally chelated 200micrograms of selenium to the methionine per day; and/or ascorbic acidpreferably in capsule form 500 milligrams to 8 g (particularly when uricacid levels are elevated and functioning as a natural antioxidant), individed dosages. The effects of the compositions can be long-lasting,with benefits extending for six months or more after therapy isdiscontinued.

The pharmacodynamic basis for successful unexpected therapeutic resultswith the compositions of the invention include (a) hydrogen bonding, (b)anionic charge, (c) electrostatic polar forces, (d) van der Waal forces,and (e) zeta potential associated with the non-covalent interactionswith the macromolecules.

In addition to having anti-inflammatory and tissue healing activities,the compositions provide a biochemical environment in accord with thelaw of mass action that can activate inactive genomic components andincrease expression of one-third or more of the genome therebypotentially countering disease including hereditary conditions. This cancounter a genetic imbalance and can therefore overwhelmdisease-producing genes, even those produced by hereditary changes.

In addition the pharmacodynamic basis for the effects of genetic therapynon-chiral function in a self-perpetuating mode through the Ltetrahedral 3D fit of L-amino acids and glycine non-covalent biochemicalmacromolecular binding to D polysaccharides such-as but not limited tothe genetic system macromolecules DNA, RNA, ribosomal RNA and ribosomesand their respective polymerases furthered by the law of mass actionmediated by progressive: therapy with synthetic therapeutic stemcell-like subject composition of L-amino acid and glycine. Thereby, inaddition, these pharmacodynamic effects of genetic therapy function in aself-perpetuating mode through the biochemical law of mass actionmediated by progressive therapy with synthetic therapeutic tissue andstem cell-like subject composition of L-amino acid and glycine, polarsurface-active lipids and optional inclusion of extracellular matrixscaffold.

L-tetrahedral fit; Surfaces and Tetrahedral fit of each alpha aminoacid. Surface magnification of molar ratio (protein) and reactivemoieties and tetrahedral fit in protein synthesis and as therapeuticanti-inflammatory healing therapy,

The C2 through C6 twenty L amino acids and non chiral glycine includingthe 8 C3 propionic acid derivatives are analog to such C3 propionic acidderivative, and C₄ butyric acid derivative, anti-inflammatorymedications and their reactive moieties. In contrast the routineanti-inflammatories listed in the PDR are benzene ring containingcompounds from which many medications and anti-inflammatory drugs arederived, lacking the L alpha amino acid and glycine 3D tetrahedron fitin protein synthesis, actually interfere with protein synthesis, (anon-tetrahedral 3D planar gliding action is present in anti-inflammatorymedication).

The compositions can also be employed for metabolic diseases andconditions such as Type 1 with insulin deficiency wherein the molarratio of the protein insulin may be incorporated into subjectcomposition to stimulate the production of insulin as well as replacingsuspected trace element deficiency such as but not limited to chromiumor type 1 diabetes and the diabetic state where there is adequateinsulin but with inadequate insulin receptor response which may bemodified with high HLB therapy.

The therapeutic compositions may also be specifically applied toaddiction by mimicking normal tissue metabolism and normal tissueincluding the L-amino acid glycine molar ratio of endorphin tometabolically stimulate and in fact coerce the body to produce thishormone. These same principles and therapeutic components have beenapplied in normalizing, as noted in a prior embodiment's dependency orwithdrawal symptoms such as, but not limited to, the use of drugs incontrolled substances, alcohol and/or drug and tobacco addiction in themedical patient or veterinary practice or experimental conditions suchas the animal or tissue culture. Therefore these compositions form aclinical bridge beyond other advanced technologies that have not to datefound a clinical application. Examples of suitable therapeutic usesinclude the treatment of Crohn's Disease, and in particular PediatricCrohn's Disease (PCD), a chronic, relapsing, unremitting disease withgrave, guarded prognosis for which conventional treatment includeshigh-risk immune suppressants such as corticosteroids at high doses. Inmany cases, particularly in pediatric cases, major surgical interventionis required within five (5) years of initiation of observation, withresection of up to several hundred grams of diseased organ tissue.Surgical intervention effectively arrests disease complications but hasno effect on the clinical course of the disease. In fact, many patientsrequire repeated surgical intervention. The use of these therapeuticstem cell-like subject compositions reduces or eliminates long-termcorticosteroid use in these patients along with reducing side effectsincluding but not limited to the interference and prevention of healing(so important in the management of Crohn's disease or Pediatric Crohn'sdisease) in these patients.

When these tissue normalizing principles and therapeutic subjectcompositions have been used in allergic asthmatic disease, therapeuticbenefits have included: minimizing emergency use of corticosteroids, orpossibly excluding the need for bronchodilator medication effect ofsympathomimetic medication such as the beta sympathomimetic agonists.Further minimizing emergency use of sympathomimetic medications andtheir vicious cycle, of rhinitis medicamodosa or asthmatic bronchitis orpotential bronchopulmonary equivalent asthmatic medicamentosa sideeffects seen with the past inhalation overuse of isoproterenol as thelocked lung syndrome).

Additionally, transplantation or other surgery can be averted incongenital biliary atresia (CBA), a disease that is usually fatal ifleft untreated surgically. Even though CBA has an incidence of 300 casesoccur annually in the U.S. this disease represents the most commonrational for liver transplantation in the pediatric age group.

The co-use of subject composition with the many medications availableand prescribed from the PDR extend synergistic pharmacodynamics of thesesubject compositions and may be integrated with the successfulbio-efficacy of the therapeutic effects of the compositions, exemplifiedby:

(1) reinstitution of organ and tissue function regardless of organ andtissue involved and regardless of etiology, such as but not limited totrauma;

(2) diseases of inherited predisposition such as, but not limited to,lysosomal storage diseases and deficiency diseases such as but notlimited to enzymatic deficiency including for example, lysosomal storagedisease in addition to specific enzyme deficiency replacement, residualtissue and organ dysfunction due to encroachment of distended lysosomesmay be further treated with these subject compositions. This includesHLB modulation with the added advantage of the polar surface activelipid surfactant high HLB packing parameter to synergize, facilitate andaccelerate small amounts of enzyme that may be present. This isaccomplished by increasing surface area, not only of the deficientenzyme, but also of its substrate to maximize the enzyme's metabolicactivity. By these methods, the genetic profile and pattern predisposingto disease in treatment will be minimized and normal genetic functionbecome more dominant. Include as exemplified here but not limited toeven the recessive lysosomal storage diseases.

Diseases and the syndrome of diseases may be viewed here as being analogto an insoluble crystalline ‘thorn in the side’ of the patient's tissueand metabolic processes whether diseases such as obesity with insolublefat particles, atherosclerosis with cholesterol crystals, cancer,genetic diseases lacking enzymes to fluidize and hydrophilize theselysosomal deposits, or other insoluble crystal like structures such asasbestos or silicosis. The liquid crystals provided in this discoverycharacteristic of the polar surface active lipids thereby reverses thesedisease mechanisms structures and functions whether by the highlyhydrophilic polar surface active lipid surfactant and/or by the initialaddition in Component No. 2 to disperse the fat with highly lipophilicpolar surface active lipid surfactant.

The added advantage offered by these surfactants is that by making thesecrystalline or crystalline like non-soluble metabolites randomlydispersed thereby changing entropy, energy is also provided at the sametime equivalent to energy of metabolizing fat such as palmitic acid (orthe combustion of paper) with the release of energy to complete themetabolism of these disease causing crystalline structures.

Current medication in the public domain emphasizes the use of (asexemplified in cancer) of platinum and cis-platinum and other alliedanti-cancer therapeutic agents. These agents were originally noted to belethal to infectious microorganisms and this concept was furthertranslated to the therapy of cancer.

Singular and novel to the prior art is therapy for infectious disease orfor cancer that is not dependent on its lethality to tissue and itsassociated disease but is dependent upon the principle that human tissuecan be facilitated and synergized to assume the function and structureof replicating itself, thereby replacing the vicious cycle of disease.This averts major side effects difficult to accept that are associatedwith therapeutic lethality concept, thereby normalizing human tissueusing compositions that mimic and are analog to human tissue not only instructure but also in function.

Such compositions can be used to treat neoplasms as in cancer orinfectious diseases, in overcoming antibiotic sensitivity, orinactivation without damaging or killing human tissue. In the case ofinfectious disease, the same high HLB polar surface active lipidsurfactant composition as in the anti-cancer therapeutic components asin No. 2 (which may be used alone or in concert with synthetic stem cellcontaining and components Nos. 1, 2, and 3) are used to counter suchmicroorganism invasive modalities as lipid A, LPS (lipo-polysaccharideas in toxic shock syndrome) that were formerly antibiotic resistant. Asimilar dual mechanism as with platinum, however without major sideeffect concerns.

In inflammation and degenerative diseases without giving up imperativeprotein synthesis in healing associated with the existinganti-inflammatory drugs, synthetic therapeutic stem cell containingcomponents Nos. 1, 2, and 3 can be used.

Congenital and genetic diseases can be treated using a composition of a“synthetic stem cell” containing therapeutic component Nos. 1, 2, and 3without assuming life threatening entree through the portal vein andinfectious microorganism carrier agents. For example, oral mucosaladministration can be used, (thereby bypassing portal vein delivery) inthese so targeted applications.

Trauma management can be performed with the local and systemic use of asynthetic stem cell composition containing component Nos. 1, 2 and 3,while greatly minimizing additional trauma and salvaging tissue byminimizing the requirement of debriedment. This provides a suturelesswound closure using progressive approximations with steri strips andinactivation of collagenase which has been activated bycortico-steroids, (which has become more commonly used in the managementof chronic diseases).

These foregoing treatments combined as one therapeutic unit butadministered as a single dosage or two to 4 times daily divided dosagesmay be given locally, systemically including intravenous administrationand oral mucosal delivery system companion to this series of inventions.

SUMMARY OF THE INVENTION

Compositions of the subject invention can comprise three, four, or fiveof the following components:

Component No. 1: 10 to 25 grams of molar ratio amino acids such as butnot limited to Neocate (SHS, Liverpool, U.K.).

Furthered by the law of mass action coercing the protein assemblagesystem three to four times a day, L amino acids and glycinenon-covalently bond and fit with the dextro-rotary pentosemacromolecules of the protein assemblage system's template DNA and RNAthose messenger and transfer RNA and ribosomal macromolecules.

Component No. 2: Polar surface active lipid, Phosphatidylcholine (PC)0.9 g administered one to three times daily, (American Lecithin, Oxford,Conn.) or available in component No. 1 in L Neocate; Phosphatidylserine(PS) 100 mg contained in a 500 mg complex capsule administered 1 to 3times daily, (Serinaid, Springfield, Utah); anti-inflammatory Omega 3fatty acids, 1000 mg per 2 capsules, 2 capsules two to three timesdaily, 100 mg D-alpha tocopherol antioxidant, antirancidity fish oilcomplex, with active ingredients 180 mg EPA, 125 mg DHA and/or seed oilflaxseed oil (250 mg, organically grown replacing 100 mg of DHA). HighHLB polar surface active lipid surfactants such as Tween 80 may be usedalone or with Component Nos. 1, 2, and 3 for: (a) modulation of mitosis(>normal), as a normal progression; or (b) normalizing mitosis ofcancer.

In cancer with the therapeutic use of highly hydrophilic surfactant suchas Tween 80 with its hexagonal geometric format microscopically analogto normal mitosis, as shown in other embodiments may now be used tofluidize and normalize to the normal metaphase and anaphase stages ofmitosis to progress to 2 normal daughter cells instead of being arrestedor ‘stuck’, in an analog fashion as an old phonographic record might bestuck at the mitosis organization center MOTC at which site andtransitional time a crystallization like seeding in the growth ofcrystals effect occurs with regard to the tread milling polymerizationof tubulin and microtubulin with new tubulin molecules added at thegrowing advancing end of the microtubules whereas others are lost indepolymerization at the opposite microtubulin end (at anaphasedepolymerization at this end of the microtubules occurs) until theanalog player needle is advanced or normalized as in the case in cancerwith high HLB surfactants. This high HLB anticancer activity has beenshown in foregoing and in prior embodiments.

This normal function of normal progression of mitosis may be furtherenvisioned as clasped hands which progressively separate at metaphaseand the fingers of the clasped hands completely separate and endow eachdaughter cell with the equal quantitative and qualitative complement ofDNA to continue their genetic activity. A maturation factor is alsocontained in the same Tween 80 molecule in the form of ethylene oxide(20 moles), resulting in normal progression resulting in apoptosisfollowed by new cellular regeneration. The hydrophilicity is furtherincreased not only by the 20 oxygen atoms as OH₂ in the 20 moles ofethylene oxide and six atoms of oxygen in the one mole of sorbitol butalso by the central double-bond of one mole of oleic acid interruptingthe 17 consecutive CH₂ found in the more hydrophobic stearic acid as ananalog “elbow” joint (c) Reduction in abnormal mitosis and cancer cells,approximately 50% histopathologically, after Tween 80, 0.125% ofexposure after 24-48 hours, as well as 76 to 83%% cancer cellinactivation in vitro breast cancer tissue culture monitored byinactivation of cancer cell mitochondria, (d) progression of cellularmaturation resulting in apoptosis with ethylene oxide, a maturation andripening factor for fruit in agriculture (an analog structural functionin cell physiology not taught in the prior art), a monomer of Tween 80which contains 20 moles of ethylene oxide.

All of the surfactants may be used as the equivalent weight volumedosage as the 0.125 percent dosage in these embodiments. Or may be usedwith a therapeutic dosage of 10 to 20 to 50% of the LD 50, for exampleTween 80 (with a dosage of 20 to 50% of the LD 50) LD 50 in theexperimental animals (rats and mice) is 7.5 ml per kilogram (identicalto highly lipophilic surfactant PGPR) with a Tween 80 or PGPR dosage of10 to 50% of the LD 50, in a 70 kilogram patient the starting dosagetotal daily dosage would be 50 to 100 ml, further divided into three tofour dosages daily. It must be noted that the LD 50 is based uponstudies in normal animals with normal hydrophilic/lipophilic equilibriumbalance HLB. This specialized use is for patients with abnormal HLBrequiring significant hydrophilic surfactant dosage. Therefore thislatitude expanding the dosage in these patients is therapeutic incontrast to the LD 50 studies of normal HLB animals that did not requireHLB modulation. The LD 50 for sodium lauryl sulfate 1288 mg per kilogramin the experimental animal, (rats orally) with or 900 to 1800 mg,further divided into three to four dosages daily Tween 80. Low HLB polarsurface active lipid lipophilic surfactant PGPR polyglycerolpolyricinolate 0.3% mother range of 0.01 to 0.05% to 10% may be used inany of these applications as a thrust mechanism to disperse and mobilizethe hydrophobic tissue components fat 4 to 12 hours before use offoregoing of high HLB surfactant.

Antioxidants such as D-alpha tocopherol 400 units, ascorbic acid500-1000 milligrams spansule, beta-carotene 10,000 units, along with theL amino acids and glycine of this therapeutic composition givingnon-covalent DNA macromolecular protection also helpful in thisanti-cancer therapeutic application of subject composition.

Component No. 3: The extracellular matrix can be given in the form of740 mg capsules, 4 to 6 capsules 3 times daily. The capsules comprise aproteoglycan aggregate complex of cartilage, chondroitin sulfatecovalently bonded to core proteins, further non-covalently linked tomacro molecule of hyaluronic acid and collagen (see for example,Cartilade, BioTherapies, Inc., Fairfield, N.J.). Component No. 3 istherapeutically used along with component No. 2 self-vesiculatingphosphatidylcholine with HLB of 10 to 11 and will further protect thecell and tissue.

This therapeutic formulation will further protect from radiation damageas in radiation therapy of cancer and/or radiation in regard tobio-terrorism attacks and nuclear plant accidents and in this protectivefunction joins component No. 1 in radioprotection. Observationsregarding amino acid amino groups and SH groups of cysteine should notexceed 1 g per day, however in the case of cancer, larger dosages to beconsidered such as 1 to 2 grams daily, indicate that the SH group isfurther protected by other phosphate groups as in phosphatidylcholine ofcomponent No. 2, or by the addition of adenosine diphosphate with theeffect of promoting differentiation so important in countering the mostaggressive anaplastic aspects of cancer. CSF cytostatic factor may alsobe added synergistically to compositions for this anti-cancer therapy.This may be derived from the cytoplasmic sap of the unfertilized egg andhas similar differentiation promotion factors that are anti-cancer. Thisunfertilized egg CSF cytostatic, cytoplasmic factor may be sourced andderived from any unfertilized ovum including fish eggs, includingsourcing as low allergenic risk potential frogs and/or ostrich eggssince derived from a source where exposure and sensitization has not (oronly rarely) occurred (see Example 13).

The compositions offer protective effects including but not limited tothe chelating protective effect for macromolecules including but notlimited to DNA and their protection from toxic chemicals such as heavymetals as well as antioxidant protection from radiation. The optionaladdition of antioxidants, such as but not limited to vitamin A (in theform of beta-carotene 10,000 units per day) D-alpha tocopherol, 400units, ideally chelated to 200 micrograms of selenium to the methionine,per day, ascorbic acid preferably in capsule form 500 milligrams to 8 gin divided dosages is also contemplated by the subject invention.

The inter-biochemical radio-protection of these components of syntheticstem cell therapeutic composition is analog to the protection ofaminophostine without the very sickening side effects of nausea andvomiting of aminophostine which may be further minimized (as the case inoptional co-use with any therapy with major side effects) by thissynthetic stem cell therapeutic subject composition when these threecomponents and specific dosages of subject composition are used.

Further to the use of the extra cellular matrix component No. 3 for themanagement of cancer the addition of ECM component No. 3 helps to (1)complete the copy of human tissue; (2) it also adds 50% additionalhealing capacity to a wound or disease; and (3) it is of great value incorrecting the healing deficiency of many patients requiringcorticosteroid therapy.

An anabolic medicament is also provided which is involved in tissuehealing and tissue regenerative which along with mimicking the molarratio of the 20 free non D-amino acids specified in the genetic code ofhuman tissue protein. The composition also mimics all the otheressential components of human tissue including the polar surface activelipid phospholipids, such as phosphatidylcholine, omega-3 fatty acidessential fats, as well as the extracellular matrix compositioncomprising: (1) fibrous structural proteins such as collagen andelastin, (2) adhesive glycoproteins such as laminin and fibronectin, and(3) proteoglycans and hyaluronan consisting of a core protein andpolymers of aminated disaccharides which are also sulfatedpolysaccharides and glycosylated proteins (glycoproteins).

The sulfated polysaccharides include, but not limited to chondroitinsulfate and proteoglycan complexes of cartilage wherein chondroitinsulfate are covalently linked to extended core protein molecules whichin turn are non-covalently linked to a huge hyaluronic acidpolysaccharide glycosaminoglycans polymer molecules with the aid of linkproteins. The subject compositions also provide a therapeutic correctionof the major complicating multiple metabolic component deficiencies tosynergistically continue the therapeutic correction of diseases such asCrohn's disease and pediatric Crohn's disease and specific in themanagement of regional ileitis characterizing Crohn's disease in thatthe ileum is normally the sole site of vitamin B12 absorption anduniquely here whose vitamin B12 levels are less than ten percent ofnormal: of statistical significance joining a less than ten percent ofnormal vitamin A level (retinol) correction of which locally andsystemically corrects healing deficiency in this disease associated withlong-term steroids along with a less than ten percent vitamin D level,vitamin D, E (D-alpha tocopherol) and prothrombin time in contrast toless than 20% of normal levels of red cell folate, copper, less than 30%zinc, serum folate, plasma ascorbate, less than 50% plasma selenium andhemoglobin other trace elements and minerals and vitamins and enzymestudy such as less than 90% serum and plasma glutathione peroxidase,ferritin of a total of 15 studied components) due to the ravages ofdisease (such as but not limited to progressive severe gastrointestinaldisease such as the chronic granulomatous inflammatory disease such asCrohn's disease which specifically in its pathogenesis targets the ileumand its associated negative nitrogen balance (primary to the disease perse and secondary to malabsorption and enzymatic deficiency and chronicrecurrent severe diarrhea)) and even further complications which includetherapeutic side effects such as but not limited to the side effects ofcorticosteroids which include growth retardation and interference withpubertal development.

Inclusive in this response of 450 patients collated as a multi-centerstudy is in response to foregoing therapy and is further inclusive of aresponse to vitamin, mineral, and trace element replacement therapy. Itmay be looked upon therapeutically as mimicking these normal componentsand quantitative levels of vitamins and minerals and trace elements ofhuman tissue.

Each disease group will be studied for deficiencies which will becorrected as exemplified by components No. 4 and No. 5 to complete themimicking and analog structure of normal tissue in the normalreplication of human tissue, normalizing its structure and function inorder to bring about the arrest of the vicious cycle of diseases andtheir pathogenic mechanisms.

Component No. 4: The 4th component in helping to complete and attainmimicking and analog to normal human tissue comprises vitamins,minerals, and trace elements. Utilizing documented deficiencies ofvitamins, minerals and trace elements from available studies orperforming pilot study guide lines. Exemplary deficiencies in Crohn'sdisease are documented in the examples presented. Vitamins, minerals andtrace elements can be provided in various concentrations. For example,vitamin B12 (100 micrograms), vitamin A (as beta-carotene 10,000 units),vitamin D, vitamin E, D-alpha tocopherol, Selenium 200 microgramschelated with methionine as sodium selenomethionine (or to sulfurcontaining cysteine).

Component No. 5 comprises Phytozyme, (Life Plus Int'l, Batesville Ark.),Amylase 50 mg., Bile 45 mg., Bromelain 30 mg., Lipase 25 mg., Pancreatin6× (NF.) 100 mg., Pancrelipase 110 mg., Papain 30 mg., Pepsin 70 mg.,Betaine HCl 100 mg., and Probiolic Blend 20 mg tablet.

Ingredients: Betaine, HCl, Pancrelipase, Pancreatin 6× (N.F.), Pepsin,Dicalcium Phosphate, Amylase, Bile, Bromelain, Papain, Lipase,L-Glutamic Acid, (ProBio Tx), Stabilized Probiotic Blend (Each dosage:200,000,000 pro-biotic micro-flora including Lactobacillus acidophilusDDS-1, Bifido-bacterium bifidum, Lactobacillus bulgaricus, Lactobacillussalivarius), vegetable and fruit concentrates. Deficiencies ofpancreatic enzymes are readily available in exampled disease, Crohn'sdisease, along with cystic fibrosis. Therefore, corrected here in thetherapeutic component formulations to normalize not only human tissuebut its secretions. Reversal to normal flora with pro-biotic alsoreadily available and, therefore, used here for the same therapeuticrationale of normalization of tissue, its symbiotic surface bacteria andassociated secretion contents of enzymes.

This detailed therapeutic replication of normal human tissue secretions,deficient in such diseases as Crohn's disease and cystic fibrosis, (andtherefore synergizes further complete reversal of disease tissue). Byincluding therapeutic component Nos. 4 and 5 and secretions of thetissue and the normalization of the micro-organism flora with associatednormalization of function of this gastrointestinal Crohn's diseasedtissue has made possible for this patient for the first time to furtherreduce from one tablet of the corticosteroid that this three componenttherapy has permitted to use ½ tablet instead (Triamcinalone, generic)for the first time in three decades. The side effects this patient hassustained from long-term corticosteroids has been worsening ofosteoporosis documented by two successive bone scans two years apart,recurrent bruising and failure to heal including two threats of the needfor skin graft which this subject composition stem cell-like treatmenthas prevented.

In the case of the gastrointestinal tract in diseases such as, but notlimited to, Crohn's disease, the addition of enzymatic therapy ofcomponent No. 5 and the addition of pancreatic and enzymatic replacementof deficiencies present herein normalizes the gastrointestinal secretioncomponent and byproduct of human tissue. The addition of pro-bioticmicroorganism therapy such as, but not limited to, Saccharomycesboulardii helps normalize the abnormal microflora that the diseasegastrointestinal tract such as but not limited to Crohn's diseasepredisposes to thereby even further normalizing abnormal microflora(which this vicious cycle chronic granulomatous Crohn's disease hasfostered) the gastrointestinal microflora, tissues and secretions.

An extension of treatment of the synthetic stem cell therapy subjectcomposition in the same patient as Ex. 1 with the addition of componentNo. 4 presented in detail in Ser. No. 09/639,859 and therapeuticcomponent No. 5 enzyme and pro-biotic 0.9 g tablets two tablets daily tothree times a day preferably before meals of enzyme replacement andpro-biotic microflora normalizing factor. These favorable conditionsmake it more and more difficult for the diseased tissue, such as but notlimited to chronic granulomatous disease, as in Crohn's disease andthereby reversing the vicious cycle of this disease and other diseasessuch as but not limited to Crohn's disease. This has proved itselfclinically in the embodiment example cited here wherein digestive enzymeformulation containing pancreatic enzyme replacement, (as well as bilewhich has also been incriminated as deficient in Crohn's disease) alongwith pro-biotic micro-organism resulted in flora normalization. Thepro-biotic in this case was Lactobacillus acidophilus, Bifidobacteriumbifidum, Lactobacillus bulgaricus, Lactobacillus salivarius use of inthis addition and completion of the normalization therapeutic stemcell-like repair kit formulation.

Most importantly component steps are analogous to a team or corporateapproach to the anabolic reconstructive reversal of the pathogenesis ofa complex vicious cycled catabolic destructive disease further analog tothe underlying pathogenetic mechanisms and the basis of the formerrefractory state of disease. Crohn's disease and many other diseaseswith such analogous pathogenetic destructive componential mechanisms,associated deficiencies and medication side effects can be treated withthe subject composition. Preferably to best address this disease state,all components of synthetic stem cell like subject compositionformulations are contained in the molar ratios of human tissue.

The human tissue normal molar ratios of these foregoing componentsinclude such as, but not limited to, non D-amino acids of the 20 aminoacids specified in the human genetic code, polar surface active lipidssuch as, but not limited to, cell membrane components, extracellularmatrix components, vitamins, minerals, trace elements are herein definedas being at least 90% of the composition by weight and 10% by weight orless of composition that is not in conformance with the molar ratios byweight of human tissue. Preferably the human tissue molar ratio ofcomposition of these components are at least 95 percent by weight andfive percent by weight or less not strictly corresponding to the molarratio of human tissue, and most preferably the human tissue molar ratiocomponent composition corresponding to over 99% by weight and 1% or lessnot strictly corresponding to the molar ratio of human tissue.

The prior embodiments documented such as but not limited to the reversalof the need for skin graft in wound treatment of a Crohn's patient(exemplified by adding deficient vitamin A locally to anabolic countercollagenase stimulated by long-term corticosteroids along with woundhealing anabolic zinc in the form of zinc oxide in the local andsystemic anabolic therapy using locally and systemically subject toposition synthetic stem cell-like medicament. Resulting in mechanismsalso associated with the successful reduction in the need for long-termcorticosteroid observer, in 85 percent of the 450 patients studied(multi-center studies).

The subject composition also provided for a marked reduction in thenecessity for major abdominal surgery (excisional bowel surgery andcorrection of fistulization is required in 70 percent of pediatricCrohn's disease patients in a period of conventional therapy five yearcare (data provided by the Ileitis Foundation of America) as exemplifiedby a 60 percent reduction in the need for correction of fistula bysurgical care. In the 40 percent remaining that require major abdominalbowel surgery this therapy offers a further 55 percent reduction insurgical mortality.

Pediatric Crohn's disease is a disease of hereditary predispositionhowever it this specific anti-inflammatory treatment is discontinuedafter one month of therapy (as might occur in the management childrenconsidering stomach tube administration in the past), the absence ofrecurrence is noted to be as long as six months in those thatdiscontinued treatment (70 percent fortunately do not recur in 7 to 12months of further observation after discontinued treatment). This issuggestive of a genetic therapeutic component associated with thistreatment

The therapeutic application of the subject compositions also provideanti-inflammatory therapeutic responses without the usual associatedcomplication of impairment of tissue protein synthesis and therebyfurther aggravation of negative nitrogen balance.

Documented studies here showed that further correction of thesedeficiencies added to any therapeutic plan added significantly to theprevention of this disease's significant predisposition for recurrences.Also included were enzymatic therapy and essential omega-3 EPA fattyacid fats with their contribution to this anti-inflammatory therapy aswell as the addition of extracellular matrix (ECM), and reversal ofimpaired healing (associated with pediatric Crohn's disease andlong-term steroids).

The addition of these deficiency corrections would further add to themanagement of this formerly intractable vicious progressive chronicgranulomatous disease, pediatric Crohn's disease in the growing child.Potentially contributing to the 15% of patients (vs. the 85%) that werenot able to replace corticosteroids.

The components of the subject invention can, in some embodiment, becombined to form compositions. For Example, components No. 1 and No. 3can be useful for anti-inflammatory or healing. Component No. 1 can beused to aid in protein formation and component No. 2 can be used toreplace damaged cell membranes. Component No. 3 increases tensilestrength of wound by 48% in more than 100 patients multi-center anddouble-blind, as well as in controlled animal studies and component No.2, modified PC lysolecithin triggers onset of protein synthesis workingsynergistically with component No. 1.

Liquid crystal high HLB surfactants HLB>13 specifically 15-16 to 20 witha high packing parameter of less than ½ and contributing a highrepulsive of charge zeta potential along with an increase in surfacearea and thereby synergize enzymatic activity of enzyme in associationwith a substrate, (thereby synergizing component No. 5) and as ananti-cancer agent also down modulating mitosis (in vitro documentationin prior embodiments) and especially in the use of Tween 80 containing20 moles (or more) of ethylene oxide a maturation factor highly usefulin the stimulation of apoptosis, a highly useful anti-cancer feature.The anti-cancer therapeutic features may be used alone or in conjunctionwith components 1, 2 and 3 as well as components one, two, three, fourand five.

These subject compositions may be administered orally or parenterally orlocally and in special applications as in anti-cancer may even beadministered intra-arterially as therapy used in conjunction withroutine medications to reduce side effects and synergize these companionmedications and thereby lessen the dose required of routine medications.

In simulating all stem cell biochemical biophysical features simulatedresults as evidenced by averting need for an organ transplant whileavoiding key stem cell side effects:

(1) Bioethics independent of use of human embryonic tissue, but canbuild and rebuild thereby enhancing tissue healing, protein synthesis onexisting tissue and in vitro recombinant DNA tissue culture,

(2) Avoiding the risk of transmission of such diseases as AIDS andHepatitis and even cancer cells (incipient),

(3) Avoiding the risk of rejection reaction and the need for HLA crossmatching,

(4) Adding a significant anti-tumor anti-cancer effect,

(5) Sourcing has avoided the risk of allergic reaction by avoidingprotein or substances that would cross match the patient's genetic code,

(6) May be used freely with other medication to reduce their significantrisk and dosage of medication.

In certain embodiments of the subject invention, a compositioncomprising: a) at least one glycosaminoglycan, proteoglycan aggregatecomplex of hyaluronic acid, extracellular matrix, protein andchondroitin, extracellular matrix compound in an amount effective in thedamaged tissue as an anti-neo-inflammatory and anti-neo-angiogeneticagent; b) about one to three grams of at least one polar surface activelipid selected from the group consisting of phosphatidic acid,phophatidylethanolamine, lecithin, phosphatidylserine,phosphatidylinositol, 2-lysolecithin, plamalogen, choline plasmalogen,phostidylglycerol, diphosphatidylglycerol, sphingomyelin, and anycombination of 2, 3 4 5 6 7 8 9 10 or of said polar active surfacelipids; c) a plurality of enantiomerically pure D-amino acids andglycine of about 9 to 25 grams; d) a component selected from the groupconsisting of polyoxyethylene Sorbitan Monooleate (TWEEN 80), Sorbitanmonooleate, grape seed extract, grape extract, and combinations thereof;and e) vitamins, minerals or trace elements selected from the groupconsisting of Vitamin B12, Vitamin E, selenium, zinc, and combinationsthereof is provided. Compositions of the subject invention can furthercomprise a compound generally accepted as safe (GRAS) selected from thegroup consisting of aspartame perfluorocarbon resins, perfluorocarboncured elastomers. [alpha]-Amylase enzyme preparation from Bacillusstearothermophilus, benzoic acid, bromelain, catalase (bovine liver),lactic acid, linoleic acid, potassium acid tartrate, propionic acid,stearic acid, tartaric acid, diacetyl tartaric acid esters of mono- anddiglycerides, ammonium bicarbonate, ammonium carbonate, ammoniumchloride, ammonium hydroxide, ammonium citrate, dibasic, ammoniumphosphate, monobasic; ammonium phosphate, dibasic; bacterially-derivedcarbohydrase enzyme preparation; bacterially-derived protease enzymepreparation; bentonite; benzoyl peroxide; n-Butane and iso-butane;Calcium glycerophosphate; Calcium lactate; Calcium pantothenate; Calciumpropionate; Calcium stearate; Carbon dioxide; Beta-carotene; Cellulaseenzyme preparation derived from Trichoderma longibrachiatum; Clove andits derivatives; Cocoa butter substitute; Copper gluconate; Coppersulfate; L-Cysteine; L-Cysteine monohydrochloride; Dextrin; Diacetyl;Enzyme-modified fats; Ethyl alcohol; Ficin; Glucono delta-lactone; Corngluten; Wheat gluten; Glyceryl monooleate; Glyceryl behenate; Glycerylpalmitostearate; Helium; Inositol; Insoluble glucose isomerase enzymepreparations; Isopropyl citrate; Animal lipase; Magnesium carbonate;Magnesium chloride; Magnesium hydroxide; Magnesium oxide; Magnesiumphosphate; Magnesium stearate; Magnesium sulfate; Malt; Malt syrup (maltextract); Manganese chloride; Manganese citrate; Manganese gluconate;Manganese sulfate; Microparticulated protein product; Mono- anddiglycerides; Monosodium phosphate derivatives of mono- anddiglycerides; Niacin; Niacinamide; Nickel; Nitrogen; Nitrous oxide;Peptones; Pancreatin; Papain; Pectins; Pepsin; Potassium bicarbonate;Potassium carbonate; Potassium chloride; Potassium hydroxide; Potassiumlactate; Propane; Pyridoxine hydrochloride; Rennet (animal-derived) andchymosin preparation (fermentation-derived); Riboflavin;Riboflavin-5′-phosphate (sodium); Sodium benzoate; Sodium carbonate;Sodium hydroxide; Sodium hypophosphite; Sodium lactate; Sodiummetasilicate; Sodium propionate; Sodium sesquicarbonate; Sodiumtartrate; Sodium potassium tartrate; Starter distillate; Stearylcitrate; Thiamine hydrochloride; Thiamine mononitrate;[alpha]-Tocopherols; Triacetin; Tributyrin; Triethyl citrate; Trypsin;Urease enzyme preparation from Lactobacillus fermentum; Vitamin A;Vitamin B12; Candelilla wax; Carnauba wax; Bakers yeast extract; Zein;Sulfamic acid; Clay (kaolin); Ferric oxide; Iron oxides; Japan wax; Talloil; Alfalfa; Allspice; Almond, bitter (free from prussic acid);Ambrette; Angelica root; Angelica seed or stem; Angostura; Anise;Asafetida; Balm; Balsam of Peru; Basil; Bay leaves; Bay; Bergamot(bergamot orange); Bois de rose; Cacao; Camomile (chamomile); Capsicum;Caraway; Cardamom seed (cardamon); Carob bean; Carrot; Cascarilla bark;Cassia bark, Chinese; Cassia bark, Padang or Batavia; Cassia bark,Saigon; Celery seed; Cherry, wild, bark; Chervil; Chicory; Cinnamonbark, Ceylon; Cinnamon bark, Chinese; Cinnamon bark, Saigon; Cinnamonleaf, Ceylon; Cinnamon leaf, Chinese; Cinnamon leaf, Saigon; Citronella;Citrus peels; Clary (clary sage); Clove bud; Clove leaf; Clove stem;Clover; Coca; Coffee; Cola nut; Coriander; Corn silk; Cumin (cummin);Curacao orange peel; Cusparia bark; Dandelion; Dandelion root; Dill; Doggrass (quackgrass, triticum); Elder flowers; Estragole; Estragon(tarragon); Fennel, sweet; Fenugreek; Galanga (galangal); Garlic;Geranium; Geranium, East IndianGeranium, rose; Ginger; Glycyrrhiza;Glycyrrhizin, ammoniated; Grapefruit; Guava; Hickory bark; Horehound(hoarhound); flops; Horsemint; Hyssop; Immortelle; Jasmine; Juniper(berries); Kola nut; Laurel berries; Laurel leaves; Lavender; Lavender,spike; Lavandin; Lemon; Lemon balm (see balm).; Lemon grass; Lemon peel;Licorice; Lime; Linden flowers; Locust beanLupulin; Mace; Malt(extract); Mandarin; Marjoram, sweet; Mate 1; Menthol; Menthyl acetate;Molasses (extract); Mustard; Naringin; Neroli, bigarade; Nutmeg; Onion;Orange, bitter, flowers; Orange, bitter, peel; Orange leaf. Orange,sweet; Orange, sweet, flowers; Orange, sweet, peel; Origanum; Palmarosa;Paprika; Parsley; Pepper, black; Pepper, white; PeppermintPeruvianbalsam; Petitgrain; Petitgrain lemon; Petitgrain mandarin or tangerine;Pimenta; Pimenta leaf; Pipsissewa leaves; Pomegranate; Prickly ash bark;Rose absolute; Rosa; Rose; Rose buds; Rose flowers; Rose fruit (hips);Rose geranium; Rose leaves; Rosemary; Rue; Saffron; Sage; St. John'sbread; Savory, summer; Savory, winter; Schinus molle; Sloe berries;Spearmint; Spike lavender; Tamarind; Tangerine; Tannic acid; Tarragon;Tea; Thyme; Triticum; Tuberose; Turmeric; Vanilla; Violet flowers;Violet leaves; Violet leaves absolute; Wild cherry bark; Ylang-ylangi;and; Zedoary bark, or any combination of said compounds. Anycombinations of the compounds GRAS can be used in formulatingcompositions of the subject invention. In some embodiments, thecomposition further comprises a flavorant that can be a fruit juice,such as tomato juice.

The following sections of Title 21 of the Code of Federal Regulationsare hereby incorporated by reference in their entireties (with respectto materials generally recognized as safe (GRAS)): §§ 5, 25, 170, 172,173, 177, 182, 184, 186, 570, and 582.

I have discovered the basis for a dependent unifying medicamentcomposition of matter which serves the basis for synergistic healingtissue regeneration activity analog to and mimicking not only embryonicstem cell but adding concentrated adaptive components to provide furthertherapeutic synergy when used alone or in combination with stem celltherapy.

This composition comprises (1) L-amino acids and glycine; (2) cellmembrane components; and (3) ECM, which also includes the colloid matrixtissue water imbibing, additionally unique combination of colloidalfactors and emulsifying factors, was not anticipated in the prior art. Ihave not found that those skilled in the art of emulsion technology (whoalso practice the art of colloid technology), let alone theincorporation and integration of biochemistry, bio-physics, clinicalmedicine, therapeutics and drug discovery required for this integrationinto a vital tissue therapeutic efficacy. All this has been accomplishedwithout any of the major concerns and breaches of bio-ethics.

(1) polar surface active lipids of anabolic tissue components comprising(and endowing the healing and tissue regeneration components of normaltissue representative of tissue) in their normal ratio includingcomponents to contribute, produce and maintain the vital colloidal andemulsion systems of the body. All components in accordance with thegenetic code and stem cell tissue without standing features of promotingtissue healing and tissue regeneration;

Embodiments of molar ratios of human tissue include fibrinogen,endorphin, breast tissue and its holocrine gland equivalent breast milk,may include muscle protein such as myoglobin which may be calculated aslisted in biochemical text references containing in this case 153L-amino acids and glycine (SEQ ID NO: 1): GLSDGFWQLVLNVWGKVEADIPGHGQEVLIRLFKGHPETLEKFDKFKHLKSEDEMKASEDKKHGATVLTALGGILKIKGHHEAETKPLAQSHATKHKIPVKYLEFISECIIQVLQSKHPGDFGADAQGAMNKALELFRKDMASNYKELGFQG, from which amino acid list molar ratios are readilycalculable.

(2) The foregoing synthetic stem cell-like therapeutic subjectcomposition must be prepared free of catabolic components and factors(that counter the maintenance of required equilibrium such ashydrolipophilic/lipophilic equilibrium balance factors that maintain thebody's emulsion and colloidal states and that are antagonistic toanabolic tissue components and further unwanted synergism contributoryto disease mechanisms) such as, and not limited to stereothree-dimensional misfits including D-amino acids, and disease responseproducts of debris (that extending disease mechanisms by seeding ofcrystallization and causing crystalline matter that promotes foreignbody reactions of disease) and protein or DNA not in accordance with thegenetic code and without any protection for protein mis-folding thatpromotes crystal shard formation and foreign body rejection reactions ofdisease. Composition components are optionally inclusive ofextracellular matrix post translational protein which is not contrary tothe genetic code. Catabolic products further to be excluded:Microorganisms intact or killed as in pasteurized products such as milkand dairy products (such organisms can be excluded via ultrafiltration).

Bringing protein synthesis as a means of anti-disease therapy where themolar ratio of the component protein amino acids not only satisfiesnormal human tissue but also approaches the formation of fetal humantissue is a goal of the subject invention. This protein synthesis alsothereby more readily and synergistically satisfies another equilibriumof protein synthesis, and thereby reverses the negative nitrogen balanceequilibrium characteristic of disease. This positive nitrogen balanceequilibrium satisfies the law of mass action by offering these preformedmonomeric components of human tissue protein to synergistically expeditecomplete tissue protein synthesis resulting in a more feasible drugdosage with more patient compliance. For example, compositions of thesubject invention can contain a dosage of 50 to 100 grams of L-aminoacids and/or glycine in contrast to an 80% to 90% larger dose of 500grams per day which is no longer considered an acceptable dosage formedication.

Additionally, monomeric amino acids of the subject composition can besubstituted with other monomeric amino acids. For example: tyrosine (P)(with two hydrophilic hydroxyl groups) is a potential substitute forphenylalanine (F) (with only one hydroxyl group). Similar conservativesubstitutions include: glycine (G) for alanine (A); methionine (M) forisoleucine (I); glycine (G) for valine (V); aspartic acid (D) forglutamic acid (E); isoleucine (I) for valine (V); serine (S) forthreonine (T), arginine (R) for lysine (K). Of course, the reverse ofthese amino acid substitutions can also be performed at the discretionof the practitioner.

We have thus countered two disruptive equilibrium of disease: (1) thenegative nitrogen balance and (2) the disrupted hydrophilic lipophilicbalance equilibrium. In so doing we have (1) expanded the genomicenvironment thereby adding therapeutic elements while minimizing geneticpre-disposition estimated to be present in ⅔ of all diseases, and (2) wehave corrected the gastrointestinal and subsequent tissue environmentinitiating the disturbance in the HLB balance.

This therapeutic composition of matter incorporates the pivotalstrategic components that maintain and form these emulsion and colloidalmicellar charged particulate matrix states as an anabolic organizedstructural and functional cell and its cytoplasmic, nuclear andorganelle components along with tissue and organ states that are analogand mimic the component factors and forces of the tissue healingregenerating stem cell. This is in sharp contrast to disease and itsassociated components factors and forces that contribute to disorganizedclumps of cells and their organelle and nuclear contents that not onlylack these required unifying forces in disease states but are alsocatabolic and disruptive to the state of normalcy and health that stemcell therapy contributes.

(3) Furthermore to this therapeutic end, the synthetic stem cell-likesubject composition of each of component 1, 2 and 3 serving as emulsionforming and thereby unifying liquid crystal micellar polar surfaceactive lipid with components of No. 3 also contributing to the unifyingcolloidal state all analog to and mimicking in a unitary modus operandithrough biomolecular engineering of the bio function and structure ofthe stem cell. It is this unique strategized fit with specializedvariations (countering through these embodiments specific dysfunctionaldisease groups), that gives this synthetic stem cell like therapeuticcomposition the capacity to mimic and be analogous to the naturallyoccurring stem cell. Component No. 2 contains self-vesiculating essenceof HLB 8 to 11 or 12, ideally 10 to 11, cell membrane forming andrepairing liquid crystal phosphatidylcholine (PC), thereby increasingpliability of the red cell, blood vessel and endothelial membraneenhancing circulatory function by 25%. Component No. 2 optionallycontains high HLB surfactants with packing parameters that not onlyenhance biologic function and efficiency of protein enzymes and theirsubstrate but also promotes protein refolding and thereby normalizingbiologic function. This helps to normalize the biologic function ofdisease promoting protein structures of Alzheimer's disease, Parkinson'sdisease, and Mad Cow disease. The high HLB (13 to 20, preferably HLB of15 to 20) liquid crystal surfactants will also enhance fluidity therebycountering debris of disease, and respective seeding of crystallizationwith reversal of existent crystals. This may be documented by normalviscosity (Du nuoys of 1 to 3 centipoises). The same therapeuticcomponent modality has been successfully used in-vitro to modulatemitosis with added maturation factor molecular component promotingapoptosis thereby normalizing cancer cells, highly unique, without anyprior art anticipation that this polar surface active lipid surfactantwould have any anti-cancer effect. These same HLB modulatingrequirements are used therapeutically here in these embodiments tocounter clinically associated diseases such as, but not limited toobesity, atherosclerosis, and coronary artery diseases. In all thesetherapeutic applications of subject composition (in fluidizing with highHLB surfactant(s)) optional pretreatment with (or administration of) lowHLB surfactant(s) to disperse the fat phase can be performed to initiatethe fluidizing that high HLB surfactant(s) will finalize in 4 to 12hours.

Additional discoveries include that these selective concurrentcomponents with the foregoing specific exclusion features not only allowbut facilitate, accelerate and synergize tissue healing and tissueregeneration. When combined with component No. 3 (collagen-cartilage)these unique synergistic features permit components No. 1 and No. 2,with L-amino acid and glycine in molar ratios that mimic human tissue,to be used effectively at reduced daily dosages of 10% to 20%, (50 to100 grams) facilitate patient compliance and do not requirehospitalization for intravenous or stomach tube administration. This iscontrasted with daily dosages of 500 grams of amino acids in elementalfeeding, which are formulated as nutritional food replacement feedingsand are met with poor compliance that often require hospitalization forintravenous feedings or stomach tube administration.

This therapeutic composition is directed to the protein assemblagesynthesis system and additionally includes all the polar surface activelipid surfactants and L-amino acids and non-chiral glycine (thelipophilic of which is primarily comprised of essential amino acids andconstitutes the hydrophobic core of proteins). The hydrophiliccomponents, primarily non-essential amino acids surround and form theperiphery of the folded protein macromolecule. These polar surfaceactive lipid surfactant forces are responsible for the final foldedprotein and its biologic activity associated with zeta potential chargedclathrate thereby providing the intramolecular bonding, electrostaticbonding and van der Waal forces with associated energy and entropyforces.

Cell nuclear and organelle membranes with HLB of 8-12 are comprised ofpolar surface active lipid liquid crystal surfactants, thereby utilizingthe same intra-molecular inter-molecular foregoing bonding forces andassociated energy and entropy forces, further comprising the omega 3fatty acid fats (lipase activated in-vivo in the intestinal tract onlyto be further activated in the cellular membranes as a biologicantagonistic of highly inflammable chemokine mediator prostaglandin two)and the high 13-20 HLB surfactants and the fat dispersing low 1 or 2 to7 HLB surfactants.

Extracellular matrix polar surface active lipids surfactants furthercomprising glypicans, utilize the same intra-molecular inter-molecularforegoing bonding forces and associated energy and entropy forces withthe associated beneficial function and structure to further modulatevital organelle with particular reference to maintaining the normalcy ofmitosis and thereby therapeutic anti-cancer function.

All foregoing polar surface active lipids provide the basis of chargedand bonding forces and mechanisms with the unique synergistic componentof hydrogen bonding in the clathrate cage structure non-liquid waterformat.

These bonding features maintain life through its colloidal matrixmediated more so by hyaluronic acid a macromolecule central to theproteoglycan aggregate complex cartilage (imbibing large amounts ofwater forming a viscous hydrous colloidal gel which gives shockabsorbing and lubricant effects, particularly in synovial membrane jointcartilage connective tissue ECM, proteoglycan aggregate complexparticularly so with macro molecular bio efficacy of hyaluronic acidbiomolecular centrality in cartilage of component No. 3 and componentNo. 2 emulsion oil and water matrix systems with pivotal effect of theliquid crystal surfactants polar surface active lipids and their highlyeffective surfactant packing parameters increases surface area and zetapotential hydrogen bonding electrostatic forces and van der Waal forces)and thereby prophylactically and therapeutically lead therapeutic“combat” in normalizing the forces of disease that promote the breakdownof the systems representative of disease, liver disease or skin death.Without these components we would be “only a lump of cells (Robbins,Harvard edition pathology text).

These three component of therapeutic synthetic stem cell like subjectcomposition polar surface active lipids surfactant component sharesemiconductor signaling systems with extracellular matrix component(ECM) component No. 3 (comprising collagen, fibronectin, laminin, andintegrins, associated growth factors and protein aggregates includingvinculin, talin, alpha actinin) and various combinations thereofsignaling protein synthesis (associated with component No. 1), a cellgrowth and differentiation and motility by collectively initiating andintegrating intracellular and intranuclear messages and nuclear signals.

In addition, the liquid crystal high HLB component No. 2 prevents andreverses non metabolizable debris of disease seeded crystals ofcholesterol crystals, calcium phosphate crystals, uric acid crystals,pigmentation debris exogenous disease causing crystal shards such assilica and asbestos. The relation of inflammation and cancer can beillustrated by the unfortunate pathologic ending to asbestosis ofcancer, mesothelioma, with the clinical therapeutic applications hereinof this science and therapeutic synthetic stem cell-like subjectcomposition.

Component No. 3 can further include all the hydrophilic components ofextracellular matrix such as, but not limited to, the proteoglycanaggregate complex of cartilage containing hyaluronic acid covalentlybonded to extracellular matrix protein and further non-covalently bondedto sulfated GAG such as, but not limited to, chondroitin sulfate.

(1) The subject composition also provides a “unique and novel andexciting in that therapeutic product and action in the patient isdependent upon the completion of the final activity and activation stepsand in a sense, the final touches of “manufacturing” steps of thistherapeutic product occurs in vivo in the patient.”;

(2) The subject invention completes the therapeutic composition to makenon-healing tissue heal and regenerate;

(3) Prior to the subject invention, those skilled in the art were unableto use Periodic Table as utilized in PDR pharmaceutical and chemicalplant whose manufacturing action is complete per se and only in vivoprocessing primarily concerns excretion and prior inaction;

(4) The subject invention uses pre-made (until available syntheticallyas in the analog case historically and in the case of past drugdiscovery and pharmacognosy of thyroid and insulin made available fromthe major meat packing houses) biologic chemical components with thepracticality and safety of GRAS components significantly expediting andmaximizing the practicality of new product discovery and developmentmaking these products readily available for market and patient use;components No. 1 and No. 2 contain essential components and that thebody cannot synthesize (e.g., essential amino acids); component No. 2contains essential lipids including omega 3 fatty acids (which becomeactivated by lipase pancreatic enzyme in the small intestines andalkaline medium and which are inactive until hydrolyzed into fatty acidand glycerin as exemplified by documentation in heart muscle cells invitro) in normalizing and preventing fatal dysrhythmia); and componentNo. 3 contains polar surface active ECM lipid glypicans (one of thethree major classes of proteoglycans GAG with its lipid foot anchor onthe adjacent (primarily lipid) cell membrane).

(5) Stem cell-caused healing and tissue regeneration can be maintainedif contact associated with component No. 3 highly hydrophilicextracellular matrix components along with foregoing glypocans in totoas analog and stimulating the activation of the stem cells in otherorgans, (specifically exemplified by ECM basement membranecomponent=Heparan Sulfate GAG a sugar polymer highly polar negativelycharged surface effect in common with polar surface active lipidspermitting the maintenance of activation of the stem cells of the skinin normal spontaneous skin repair and regeneration after injury). Thisextracellular matrix basement membrane surface effect in maintainingstem cell character includes interaction with collagen, with several ECMmacromolecules illustrating the rationale of the extracellular matrixand component No. 3 stem cell-like subject composition therapeuticeffect characteristic including the glycoprotein laminin, the highlysulfated glycoprotein entactin as well as heparan sulfate GAG,extracellular matrix components included in other embodiments. Theseforegoing proteoglycan are noncovalent electrostatic interaction chargedbonds between the negatively charged GAG and positively chargedextracellular matrix proteins. Cartilage cells or chondrocytes in asimilar ECM contact fashion also remain differentiated only as long asthey are in contact with collagen.

(6) Additionally, a similar surface stimulus effect was noted inSteri-strip suture less wound approximation and healing (in view ofsuture intolerance and breakdown because of prolonged steroid use) woundedges contact approximation, repairing the rift in the basal epithelialproliferating cells and associated stem cells and their stem cellbasement membrane maintenance contact with ECM collagen, proteoglycanaggregate complex which stimulated skin cell differentiationaccelerating healing, the absence of scar formation, and stoppedproliferation and migration of epidermal cells in conjunction with localand systemic therapeutic stem cell like composition.

(7) In further keeping with the synthetic stem cell-like synergisticformulation component collagen and its associated proteoglycans, thetherapeutic stem cell-like composition has been found: (1) to maintainthe stem cell activity, (2) to be one of the first substances to beformed after cleavage of the fertilized ovum again showing itsimportance in the stem cell activity), (3) stem cell activity is againseen when collagen-cartilage is added to a wound and thereby stimulateshealing, and increase the hill disease or wound tensile strength by morethan 48 percent, (4) directing the L-amino acid and glycine to stem celltissue protein formation is synergized by analoging molar ratios ofhuman tissue profiles (focused in continuation of fetal and embryonicanalog to breast milk and breast tissue best directed and utilized inand the specialize in these are the developing embryonic fetus andneonate with the largest population of stem cells). These stem cellsactivated efficiently with significantly more focused on stem celltissue protein synergistic through these synthetic stem cell therapeuticsubject compositions thereby providing lower effective dosagerequirement associated with maximal bioefficacy and biosafety andpatient compliance for tissue healing and tissue regeneration than inthe nutritional form.

(8) All components, and potential further added components for specialdisease groups, provide for therapeutic application of the subjecttechnology that when co-used maximize efficiency and therefore lessenthe required dosage of each component through their synergy (directed tothis stem cell-like therapeutic subject composition dedicated tostimulate, facilitate and accelerate in-vivo the patient's stem cellsthereby promoting this tissue healing tissue regeneration effect). Thisin turn, through progressive intermediate steps, finalizes in-vivo theultimate activated therapeutic pharmacodynamic medication.

(9) The body's further action on components Nos. 1, 2 and 3 with theoptional addition of further components as outlined in these embodimentsincluding components No. 4 and No. 5 to products is devoted to excretionand metabolic degradation that precedes excretion of these products.

(10) I have in conclusion further unexpectedly discovered through theseseries of inventions many medicaments to help reverse groups of diseasesthrough the medium of this stem cell-like therapeutic composition. Thefurther basis of which is extracellular matrix representation asmesodermal and future mesenchymal tissue which has the ability intact tomaintain stem cell activity of the skin. For example, if the skin basalepidermal stem cell layer is separated or severed or broken as in awound from the underlying collagen proteoglycan aggregate complex ofbasement membrane stem cell surveillance that healing tissueregeneration is arrested. Molecular embryologic studies prove if themesoderm and its future extracellular matrix are removed from its normalintermediate contact position these ectodermal and endodermal surfacesdegenerate.

(11) Variants of these components with further specialized biologiceffect can be found in the developing fetus with the largest populationof stem cells, and sourcing from various species so providesrepresentative biomolecularly “origin of species” also seen fetusprovides these specialized functions and therapeutic opportunities. Forexample, the allantoic stage of the developing fetus produces readilysoluble allantoin as to animals and birds a product of purine metabolismin its urinary tract, whereas the adult excretes highly insoluble uricacid making some adults prone to gout. By deriving enzymes such asuricase, from such animals, the soluble stage of allantoin can beachieved thereby alleviating the metabolic disability of gout. Thisanalog sourcing of enzymes or synthetic models for synthesis offer manyother such examples of therapeutic application.

For example, in addition to shark and cow tracheal cartilage, none ofthe cartilage at this specified level has proceeded to bone formation.For specialized therapeutic indication and application in impendingamputations, such as, but not limited to, the use of stone crab,starfish, (echinoderm biologic class) and newt (salamandridea family, anamphibian), extracellular matrix (or cartilage), with multiple enmeshedgrowth and de-differentiation biologic factors, from an animal that canreplace its own amputated limb and is in the activated biologic processof so doing can be utilized. This initially can be administered as afood and then ultimately desiccated and pulverized in accordance withthe state of the art of production of biologic extracts. Thisde-differentiation extracellular matrix mechanism added to ECM componentNo. 3 (synthetic stem cell like therapeutic composition comprisingcomponents No. 1, 2, 3) a starting dosage of 1 to 2 grams ideally takingcompositely and synergistically with the other three components butoptionally may be used alone three times a day could prove ofsignificant value in a patient such as a soldier suffering fromimpending phases of traumatic amputation on the battlefield. A dosagerange 1-50 grams, added to ECM of component No. 3, specializing andvarying these options according to the challenging needs of the diseasein question.

(12) This may be further exemplified by drawing from the functionaladvantages of cellular membrane CM component No. 2 with the use of polarsurface active lipids liquid crystal high HLB surfactant such as but notlimited to Tween 80 in a cancerous group of diseases to modulatefunctionally than the nuclear organelle in mitotic organizing centermitosis and apoptosis to normalize the cancer cell. This subjecttherapeutic composition of matter opportunity can be further maximizedby comparing therapeutic response results with esterifying theethoxylated grouping with an additional 20, 40 and 60 or more moles ofesterified ethylene oxide to achieve the results desired. Again thistherapy may be used alone but ideally further synergized as part of acomponent No. 2 of the entire three component synthetic therapeutic stemcell-like subject composition. Additional synergistic efficacy of thesubject compositions in expanding, synergistically, the genome(potentially mutated) can further normalize DNA along with antioxidantsvitamins E, C, and A and synergistically broadening this uniquecomposition for use in anti-cancer activity. Other enzymes otherwisenormal but deficient such as but not limited to polymerases may beactivated, facilitated, stimulated and synergized by the packingparameter efficiency and increase of surface area by the same polarsurface active lipids liquid crystal surfactants. The foregoing arerepresentative of medicaments and drug discovery application technologyin therapeutic compositions unanticipated in the prior art.

(13) The same foregoing therapeutic, biomolecular pharmacodynamicapplication technology may be applied to the proteinopathy pathogenesisof Alzheimer's, Parkinson's, Mad Cow disease and associated humantransmissible diseases resulting from mis-folded proteins from AlphaHelix random coil, to abnormal beta sheet, and reverse the foldingmechanism with the foregoing high HLB surfactants.

Captured in this medicament are all of the vital healing and tissueregeneration forces of the living stem cell, unanticipated in the priorart, not only strategized, in biomolecular engineering as such but alsoestablished bio-efficacy as such. The achievement of this goal with sucha degree of bio-efficacy and safety was not only unanticipated by theprior art but this degree of excellence of reproducing the vital forceand effect of live tissue was not anticipated by the inventor. It isonly through this extension of strategized vital tissue that thishealing tissue regeneration therapeutic factor with all its componentsand bioefficacy can be extended for further continued replication intothe tissue itself, an unanticipated accomplishment in therapeutic agentsto date.

For example, fetal neonate tissue (whose amino acids molar ratios areanalogous to and mimic the tissue and its properties of tissue healing,tissue restoration and regeneration) with further unique combinedproperties of protein synthesis coupled with anti-inflammatory activityas well as a genetic factor not found in anti-inflammatory medicamentsof the prior art. Additionally not found in the prior art is theselective choosing (from the biologic period table) of amino acids inmedicament dosage form synergistically adapted to the human stem cellfunction (in contrast to the multiplicity of nutritionally basedelemental feedings used as a medical food rather than a medicament.

I have additionally discovered and utilized a unifying cell and tissuecomposition that is analogous to and mimics the structure and functionof the stem cell emulsion and colloidal bonding force and matrix thatextends itself to the tissues. The composition can be given, not onlyparenterally, but more importantly, orally, with further benefit of theoral mucosal delivery system. These bonding forces are liquid crystalsurfactant micelle polar surface active lipids incorporate the zetapotential, hydrogen bonding and clathrate structured, non-liquid, watercage, thereby, extending and disseminating this tissue structure bondingand unifying force to the patient's tissues.

Most important of all in this therapeutic breakthrough, unanticipated inthe prior art, is the anti-cancer activity, independent of all the priorstrategy of killing the cancer as if it were an infectiousmicroorganism, but instead adopting a normalizing factor in thetreatment of cancer: modulation and normalizing mitosis using highlyhydrophilic liquid crystal micelle surfactant fluidizing (with anethylene maturation factor) and normalizing the cell and tissue with itsprogression of maturation to apoptosis.

In regard to pathogenic microorganism antibiotic resistance and testingfor same in vitro the addition of component 2 alone, and in totocombination with the subject composition may counter microorganismpathogenic components such as lipid A and LPS lipopolysaccharide.

Omega 3 oils and Vitamin E (100 units), can be added as a synergisticantioxidant and anti-rancid component further with the omega-3 fish andseed oil synergistic to the anti-inflammatory efficacy of thecomponent 1. In vivo activated, further promulgating and synergizinganti-inflammatory activity without disrupting the essential tissuereplacement component of protein synthesis, not found or anticipated inall prior art and anti-inflammatory compounds.

Extracellular matrix (ECM)—only animal tissue of these components—nonmammalian thereby any DNA would be unique enough so that not recognizedas potentially damaged DNA that could bring about unwanted mutationsfrom which catabolic disease producing factors could be antagonisticallyderived.

In allergic anaphylactic type rejection like reactions in regard tomultiple severe food allergies distant biologic components sourced fromnon-mammalian animals (such as amphibian derived foods have been foundto serve as a universal food donor) can be used. Extracellular matrixcomponents additionally can, preferably, be utilized in this therapeuticcomposition in the encapsulated powered form, in contrast to acompressed tablet.

This continuity of proliferating cellular contact with extracellularmatrix collagen proteoglycan aggregate complex as exemplified by, butnot limited to the basement membrane and the ECM collagen contactsupportive maintenance of the active skin stem cell layer, similarobservations have been made in the cartilage cells or chondrocytescorrelating ECM contact with similar stem cell activities in cartilagetissue. Similar correlation has been noted with regard to cartilageplaced in a wound with activation of stem cells accounting for thestimulation of wound healing associated with about a 48 percent increasein tensile strength of healed wound.

The same therapeutic and prophylactic concept can be used in theunfortunate possibility of a bioterrorism attack (mediated by nuclear,microorganism, or biochemical agents). Therapeutic composition of thesubject invention can also be used in the treatment of soldiers on thebattlefield.

These anabolic components may be derived from a “biologic periodictable” with available biochemical formulations of tissue polypeptidesand tissue polypeptide proteins from which molar ratios may be readilycalculated (sources include the Merck index, the Code of FederalRegulations (CFR 21), and public databases that provide the amino acidsequences of known proteins and polypeptides.

Component No. 1—the anabolic amino acids in molar ratio of embryonicfetal neonatal human tissue in the monomeric amino acid form of breastmilk and breast tissue. This synergistic human tissue molar ratiosynergizing and expediting through the mechanism of the law of massaction the final polymerized stem cell tissue protein along with itssignificant anti-inflammatory activity through amino acids that areanalog to C 2, 3, 4, 5 and 6 anti-inflammatory medications.

Component No. 2 can be used independently of, and synergistically withcomponent No. 1 and provides polar surface active lipid liquid crystalmicelle with biochemical essences of cell membrane (CM). Component No. 2can include phosphatidyl choline (PC), omega-3 fish oil, and seed oils.

These highly hydrophilic polar surface acting lipid surfactants also maybe utilized therapeutically in treating diseases mediated by mis-foldedproteins, including Alzheimer's disease, Parkinson's disease, Mad Cowdisease and its human transmissible equivalent.

Component No. 3 comprises extracellular matrix (ECM), glypicans, and/orfibronectin, collagens, proteoglycan, glycosaminoglycans, fibrinogen,and fibrin.

Fibronectin may also be used in conjunction with other structuralglycoproteins such as osteonectin SPARC secreted proteins rich incysteine, osteopontin and osteocalcin in addition to tenascin present instem cell containing tissue such as periosteum. These componentcompounds may be used in dosages in this therapeutic subjectcomposition, of one half to 2 grams with a range of 1 to 50 gramspreferably of fibronectin laminin structural glycoproteins in additionto collagen and associated proteoglycan aggregate complexes whenpossible derived from ECM of amphibian animals such as reptiles andcrabs (stone).

This tissue healing tissue regeneration therapy can be used inconjunction with many other therapies that have dramatic therapeuticeffects and high incidence of side effects that has heretofore minimizedtheir popularity and value. Administration of this synthetic stem celllike subject composition to these patients can protect them from theseside effects and the side effects can be greatly minimized. The sametherapeutic and prophylactic concept can be used in the unfortunatepossibility of a bioterrorism attack, (mediated by nuclear material,microorganisms, chemical agents) or in speeding tissue healing andtissue regeneration of soldiers on the battlefield.

Innovative Bio-Pharmaceutical Countermeasures to a CBRN Attack.Statement of the Problem Being Addressed:

-   -   A major concern in dealing with the nation's newest enemies,        that have already carried out terrorist attacks on both our        military forces and civilian populations, is that they will        momentarily escalate their assault on the U.S. to include the        use of chemical, biological, radiological and nuclear (CBRN)        attacks, for which, at present, only inadequate countermeasures        or remedies exist.    -   Research personnel in the medical, biological and physical        sciences, who have a track record of successfully undertaking        multidisciplinary programs that result in novel, cost effective        solutions to vital national problems, are here today to offer        DARPA a bold, highly innovative, bio-pharmaceutical therapeutic        advance, as a countermeasure to potential chemical, biological,        radiological and nuclear terrorist attacks.

Brief Summary of the State of the Art:

-   -   A commonly utilized reference book for physicians is the        “Physician's Desk Reference” (PDR), that contains a section        entitled PDR Guide to Biological and Chemical Warfare Response,        as well as a section on Nuclear Radiation.    -   The PDR contains information for a wide range of bacteriological        agents including, for example, anthrax, and for various chemical        agents. It describes the clinical effects that are commonly        observed, and indicates what treatments may be helpful.    -   Unfortunately, in too many instances, including nuclear        radiation, no active treatment is offerable that can save the        patient.

Proposed New Technical Approach:

-   -   In general, medicine's approach to disease processes, including:        -   malignant processes        -   infectious processes and agents        -   abnormal proteins        -   pathogenic processes        -   abnormal mis-folding of protein in the form of beta sheets            in contrast to normal alpha helix and random coil has been            to target attacking the diseased cell, with the            pharmacological approach of eliciting a cure by cell death,            either direct or indirect.    -   The above pharmacological technological approach using these        lethal agents has been initially dose-calibrated by LD50 tests        of animals to assess their lethality and relative biosafety.    -   Another approach to countering disease processes can be        correlated with the 21^(st) century breakthrough of stem cell        therapy included in oncologic therapy.    -   Looking into the environment surrounding each cell, we        discovered a colloidal microcosm that we know is representative        of our synthetic stem cell-like liquid crystal formulation.    -   This synthetic stem cell-like medication which is analog and        mimics the stem cell and its tissue in its component structure        and function, as well as based upon bio-emulsion and        bio-colloidal structural formulations, and further mimicking        human tissue is additionally unique in that it does not require        human tissue for its preparation.    -   This proposed new biomedical approach:        -   stimulates, accelerates and facilitates the patient's own            stem cells with bio-safety and the bio-efficacy of the stem            cell and augments any form of stem cell therapy        -   makes it possible therapeutically for the first times to            encounter disease in cooperation and in conjunction with,            offering therapeutic medication which is incorporated            in-vivo with the patient's own tissue resulting in healing            and tissue regeneration.    -   This new approach to pharmaceutical healing in disease        management is representative of 20 successive filed patent        application inventions including an anti-inflammatory medication        inclusive of stimulation of protein synthesis and an anti-cancer        therapeutic medication, while preventing multiple side effect        risks of existing therapeutic agents.    -   This new technical approach is based on:        -   A synthesis of clinical experience including multi-center            studies of more than 450 patients and 150 clinical            controlled studies with an 85% efficacy in both groups, and            in vitro anti-cancer controlled studies including modulation            and normalization of mitosis.    -   Studies thus far have included:        -   normalization of the body's inflammatory response and            associated protein synthesis        -   mitosis modulation effects        -   anti-cancer activity of this synthetic stem cell-like            medication        -   effects of minimizing radiation and chemotherapeutic            dosages.        -   Diagnostic procedures utilized in studying the comparative            microscopic geometric morphology have included:            -   polarizing microscopy            -   X-ray diffraction techniques.                These studies have produced exciting results in which it                could be discerned that under specific test conditions:    -   The type of liquid crystalline phase aggregation of the        component surfactants with a low packing parameter revealed        reverse hexagonal phase rods of water surrounded by emulsifier,        which correlates morphologically with the abnormal mitosis of        cancer.    -   The macroscopic appearance of this phase of bio-emulsion and        bio-colloid configuration revealed lumps of emulsifier in        equilibrium and a surplus of water.    -   Use of the surfactant packing parameter formula indicated the        least surfactant packing parameter, and associated least        repulsive particle charge.    -   It is noted that the patent pending stem cell repair kit        bio-colloid and bio-emulsion format and composition is normally        present in human tissue but is not derived therefrom.    -   Furthermore, this liquid crystal technology intrinsically        provides for and allows the three-dimensional macro-molecular        structure, as well as intra-molecular folding. The presence of        this liquid crystal also allows continuous surveillance and        maintenance to keep the cell normal.

Our preliminary conclusions are:

-   -   The patent pending liquid crystal formulation and concept allows        us to rethink our approach as to how cells or macromolecules        such as proteins maintain normalcy.    -   Our patent pending medications were derived by utilization of        custom tailoring of the components of this liquid crystal        formulation to more specifically targeted therapeutic        requirements of the disease process.    -   Remarkable bio-safety has been observed in the research to-date.

Expected Results:

The new operational capability that would be provided:

-   -   Biologically safe, efficacious, therapeutic compound, readily        taken orally or by injection.    -   Heightened immunity when taken in advance of a terrorist        chemical, biological, radiological or nuclear (CBRN) attack.    -   Accelerated healing when taken following a terrorist CBRN        attack.    -   Protection of the entire population at risk of infliction of a        terrorist CBRN insult, by mitigation of lethal morbidity (by        prevention of sickness) and lessening of mortality (by        prevention of death).    -   Dosage in proportion to body mass.

Cell Biochem Stem Cell Repair Kit, A Liquid Crystal Formulation and itsRole in Reduction of Pathogenesis

In general, medicine's approach to disease processes, whether they bemalignant, processes, infectious processes and agents or such as anabnormal protein or other pathogenic processes that have been correlatedwith progressively newer findings of disease processes such as theassociation of the abnormal mis-folding of protein in the form of betasheets in contrast to normal protein of alpha helix and random coil,(i.e., Alzheimer's disease, Parkinson's disease, Mad Cow Disease and itshuman transmissible encephalopathy, abnormal Prion (sc) Disease) havebeen targeted by attacking the diseased cell with the pharmacologicapproach of eliciting a cure by cell death either direct or indirect.

With pharmacologic technologic approach using these lethal agents havebeen initially dose calibrated by LD₅₀ tests of animals to assess theirlethality and relative biosafety.

Another approach to countering disease processes can be correlated withthe 21^(st) century breakthrough of stem cell therapy included inoncologic therapy.

Looking into the environment surrounding each cell we discovered acolloidal microcosm that we now know is representative of our syntheticstems cell like liquid crystal formulation. This synthetic stemcell-like medication which is analog and mimics the stem cell and itstissue in its component structure and function as well as based upon bioemulsion and bio-colloidal structural formulations, and furthermimicking human tissue is additionally unique in that it does notrequire any human tissue for its preparation. This medicationstimulates, accelerates and facilitates the patient's own stem cellswith bio-safety and bio-efficacy of the stem cell and augments any formof stem cell therapy. Thereby, making it possible therapeutically forthe first time, to encounter disease in cooperation and in conjunctionwith, offering therapeutic medication which is incorporated in vivo withthe patient's own tissue resulting in healing and tissue regeneration.This epitome of pharmaceutical healing in disease management isrepresentative of 20 successive filed patent application inventions: ananti-inflammatory medication inclusive of stimulation of proteinsynthesis and an anti-cancer therapeutic medication, while preventingmultiple side effect risks of existing therapeutic agents.

This medical product is a synthesis of clinical experience includingmulti-center studies of more than 450 patients and 150 clinicalcontrolled studies with an 85% efficacy in both groups. In vitro studiesinclude anti-cancer controlled studies including modulation andnormalization of mitosis.

Having studied and normalized the body's inflammatory response andassociated protein synthesis with this medication, other responses suchas the cancer response were then studied. It was noted that thismedication had a mitosis modulation, anti-cancer activity of thissynthetic stem cell-like medication and its effect in minimizingradiation and chemo-therapeutic dosages was observed progressively asfollows:

1) The comparative microscopic geometric morphology including studies ofpolarizing microscopy and X-ray diffraction that the type of liquidcrystalline phase aggregation of these component surfactants with a lowpacking parameter revealed reverse hexagonal phase rods of watersurrounded by emulsifier, which correlated morphologically with theabnormal mitosis of cancer. It was also noteworthy that the macroscopicappearance of this phase of bio-emulsion and bio-colloid configurationrevealed lumps of emulsifier in equilibrium and surplus of water.Further characterized by the surfactant packing parameter formulaindicating the least surfactant packing parameter >1 Ns (inverselyproportionate to the surfactant packing parameter) and associated leastrepulsive particle charge. This is in sharp contrast to the other phasesof this medication and tissue analog.

This formulation is explained in detail for a unique use in thenormalization of the cellular environment (both internal and externalstructural support) by supplying this colloid and emulsion system to thecellular environment which was weakened, offering further protection tothe cell from free at radical or radiation damage (see Example 13).

2) Putting this thesis to the test, in vitro, it was further found thatthe bio-emulsion and bio-colloid system components that favored thehexagonal micelle small spherical aggregate configuration with clearsolution macroscopic appearance. This was noted incubating breast tissuein-vitro culture system with ¼ to ½% of the foregoing resulted innormalization of mitochondrial metabolic activity andhistopathologically 50% reduction in the abnormal cancer cellshistopathologic morphology including similar reduction in cells withtheir characteristic abnormal mitotic figures.

With the above formulation in mind several effects upon the milieu ofthe cell are as follows:

1) effect of colloidal surrounding water molecule This patent pendingstem cell repair kit bio-colliod, and bio-emulsion format andcomposition is normally present in human tissue but not derivedtherefrom. This includes liquid crystalline bio-robotic components whichare also semiconductor signaling mechanisms derived in accordance withthe code of federal regulations from a patent pending bonding ofbiopharmaceutical biomolecular periodic table derived components. Thebio-efficacy of these liquid crystalline components is measured by thefollowing formulation of surfactant number and packing parameterstrongly hydrated surface with structured water in contrast to liquidwater and associated strong particle hydration.2) The strong particle hydration and surfactant packing parametersresult in highly repulsive forces of structured clathrate water incontrast to liquid water (with effect inverse to the surfactant packingparameter number) and equals <½. This Ns is derived from the formula v×1divided by a_(o) in accordance with the formula wherein v and 1represent the volume and length of the hydrocarbon chain. C₂, C₃, C₄,C₅, C₆, and a_(o) is representative of the area of the amphiphilicmolecular structure of these surfactant hydrophilic head groups ofcomponent #1, (10 to 25 grams loosely packed encapsulation tid).

Component #2 cell membrane composition includes liquid crystallinebio-robotic components that are also semiconductor biocomputer signalingmechanisms. The bio-efficacy of these liquid crystalline components ismeasured by the following formulation of surfactant number and packingparameter which equals ½-1 and is derived from the formula v×1 dividedby a_(o) in accordance with the formula wherein v and 1 represent thevolume and length of the hydrocarbon chain. C₁₆ and Ca₁₈ and a_(o) isrepresentative of the area of the amphiphilic molecular structure ofthese surfactant head groups component #2, (dosage 1-2 grams tid).

Component #3, extracellular matrix (ECM) glypicans, in the onlyextracellular membrane component with a liquid foot anchor with a C16 to18 hydrocarbon chain with the same formulation and surfactant number andpacking parameter which equals ½-1 is dependent upon chain length C16 toC18 and volume of the respective hydrocarbon chain and a_(o) isrepresentative of the area of the amphiphilic molecular structure ofthese surfactant head groups of component #3, (dosage 1-2 grams tid).

The foregoing components #1, #2 and #3 are dependent upon in vivoentrapment of clathrate of structured water with reduced entropic energyforces.

The remainder of component #3, the bio-colloid component structure andfunction are dependent upon in-vivo non-covalent bonding of water(dosage 1-2 grams tid).

This liquid crystal technology intrinsically provides for and allows the3-D macro-molecular structure such as proteins as well asintra-molecular folding. The presence of this liquid crystal also allowscontinuous surveillance and maintenance necessary to keep the cellnormal.

CONCLUSION

This patent pending liquid crystal formulation and concept allows us torethink our approach as to how cells or macro molecules such as proteinsmaintain normalcy.

Patent pending therapeutic medications thereby resulted, by utilizationof custom tailoring of the components of this liquid crystal formulationto more specifically targeted therapeutic requirements of the diseaseprocess.

1. Components #1, #2 and #3 comprise liquid crystal polar surface activelipids amphiphilic compounds that mediate the bio-emulsion waterentrapment.

2. Component #3 also comprises non-amphiphilic bio-colloid water bondingcompounds providing tissue turgor.

3. According to conclusions 1 and 2, mammalian, e.g. human tissuecomprises 65% to 75% water structurally and functionally held as humanbio-emulsion entrapped water or bio-colloid bonded water.

4. According to conclusion 3, mammalian, e.g., human tissue comprisescells, cell membrane and extracellular matrix providing cell and tissuestructure other than a “clump of cells.”

5. According to conclusions 1-4, bio-emulsion component surfactantpacking number Ns is inversely proportionate to the packing number.

6. According to conclusion 5, the surfactant packing number relatespolar surface active lipid surfactant amphiphilic molecular structuremathematically derived from the formula Ns is equal to V divided byL×A_(o) wherein L is the length of the liquid crystal surfactant polarhydrocarbon chain and V equals the volume of the surfactant hydrocarbonchain. A_(o) equals the area of the hydrophilic head component of thisamphiphile.

7. Non-catabolic medication components 1, 2 and 3, are tissue componentsof cellular, cell membrane, extracellular matrix and cell tissuemathematically expressed and dependent upon the mathematicalformulations expressed in accordance with conclusion 6.

8. According to conclusion 7, these bio-chemical and bio-physicalcomponents mimic and are analog to human tissue but are not dependentlyderived from human tissue.

9. These components are derived from a biologic periodic table accordingto the code of Federal Regulations CFR21 with tissue healing and tissueregeneration capacity.

10. The non-catabolic tissue healing tissue regeneration capacity doesnot inhibit the protein synthesis of tissue healing because of thetetrahedral fit of the alpha carbon in the polypeptide protein chain.

11. According to conclusion 10, compositly therefore represent thecomponents of the human stem cell according to the foregoing conclusionsand conclusion 1 unite therapeutically in-vivo as cellular, cellmembrane, extracellular matrix, cell and tissue analog and mimickinghuman tissue, resulting in the formation and regeneration of healedhuman tissue.

12. According to conclusion 1, the intrinsic interactive interplay ofhydrogen bonding electrostatic forces and van der Waal forces and C2 toC6 amino acids result in a protein molecular folding characterizing thebio-activity of macro-molecules as protein resulting from its templateaction of DNA upon RNA upon ribosomes.

Pharmacology and Pharmacodynamic Rationale Sourcing of Q101 KC forCrohn's Disease and Pediatric Crohn's Disease. Q101KC:

In summary, the synergistic anti-inflammatory effects of components of#1, 2, and 3 are:

-   -   component 1: 80% reduction of inflammator chemonikines    -   component 2: Biologic competition countering prostaglandin (PG2)    -   component 3: Reduction of new blood vessel angiogenesis thereby        reducing inflammatory response

Summary of the tissue healing and regeneration effects of Component Nos.1, 2, 3, 4 and 5 are:

-   -   Component No. 1: tissue protein synthesis and cell membrane        repair    -   Component No. 2: cell membrane repair and replacement    -   Component No. 3: 48% increase in tensile strength    -   Component No. 4: 90% reduction and risk of sepsis        -   (Balanced B complex including B2 and B12)    -   Component No. 5: implantation symbiotic probiotic bacterial        flora to perpetuate the prevention of tissue damage and        replacement of deficient enzymes which together perpetuation the        effects of Component No. 1.

The bio-science of Q101KC is based upon a series of patent pendingnon-covalently bonded inventions serving as therapeutics of CD (Crohn'sDisease). As seen here, particularly important in a chronic disease suchas CD, the failure of healing is the basis of the chronicity of thedisease. Therefore this is the basis of the direction of this treatment.This can be best appreciated by realizing that disease, as well as woundhealing and tissue regeneration, represent an integral part ofinflammation. Therefore, the same components that are crucial forproviding molecular embryonic development may also serve as a ‘stem cellrepair kit.’

Once can now readily see why the stem cell (or its equivalent here)addresses these therapeutic needs. The development and sourcing ofcomponents of this CD therapy mimic human tissue in its structure andfunction.

The family of anti-inflammatory drugs, best exemplified by aspirin (ASA)and 5 ASA dramatically reverse inflammation. However, they alsosignificantly impede tissue healing and tissue regeneration. Theseanti-inflammatory drugs impede healing and tissue regeneration throughinhibition of protein synthesis; a therapeutic cost that a patient witha chronic disease such as CD cannot afford.

This molecular basis of Q101KC focuses on tissue healing and tissueregeneration, mimicking human tissue in all of its structures andfunctions. This molecular basis of therapeutics, presently directedtoward Crohn's disease, utilizes non-covalent bonding along with theelectrostatic charged particle potential of colloids, a significantfeature of human tissue and also synergistic to healing and tissueregeneration. This treatment has been developed as a new patent pending,cost-effective drug discovery technology.

Q101KC facilitates, accelerates and synergistically reestablishes normalhuman tissue in accord with the intact colloidal domain of all tissuesfrom the ECM (Extracellular Matrix). This proteoglycans complex bindslarge amounts of water forming a viscous hydrate gel, which givesconnective tissue the ability to resist compression. The resultingresilience and lubricity and associated electrostatic charge increasetensile strength of disease tissue and improve wound healing by 48%.

The same advantages are endowed in the emulsion technology features ofComponent Nos. 1, 2, and the lipid anchor of glypicans of Component No.3. Component No. 1 encompasses the 20 alpha amino acids of the humangenetic code for tissue protein formation which is so imperative in thehealing process. Component No. 2 provides for cell membrane regenerationin disease tissue by self vesiculation of PC ** (phosphatidyl choline)in addition to the healing of cell membrane aided by the glycine aminoacid component of #1, and also provides cell membrane-focused omega 3antiprostaglandin, a potent anti-inflammatory factor. Workingsimultaneously and synergistically with Component No. 2 is Component No.3, an ECM proteoglycans complex, which further normalizes human tissueand counters lipid prostaglandin's most profound inflammatory mechanism.Component Nos. 2 and 3 simultaneously and synergistically provide tissuehealing and tissue regeneration.

The gel hydrate of the colloidal domain is remarkable and unique to thisnew drug discovery technology and Q101KC. Component Nos. 1, 2 and partof Component No. 3 with its lipid cell membrane anchor glypicans aresimilarly effectual in tissue regeneration and healing. The liquidcrystal of all these forgoing components of emulsion technology aid intheir liquid crystal alignment effects in the healing of diseased tissueas in CD.

Description of the Rare Disease or Condition, Proposed Indication, andReason for Therapy. Description of the Disease or Condition:

PCD, like Crohn's disease, is an idiopathic, chronic, transmuralinflammatory process of the bowel that can affect any part of a child'sgastrointestinal tract. The small bowel, and particularly the terminalileum, is most commonly affected, although the colon, small intestinealone, stomach, and esophagus may also be affected. PCD is believed toresult from an imbalance between pro- and anti-inflammatory mediators.PCD often presents itself with abdominal pain, weight loss, anddiarrhea, which may be complicated by intestinal obstruction and/orfistulization.

The inflammation of tissue in PCD patients causes numerouscomplications. The most common complication is intestinal blockage.Intestinal blockage results from a thickening of the intestinal wallfrom swelling and scar tissue, which, in turn, narrows the intestinalpassage. Although the obstruction in PCD patients is initially caused byedema of the mucosa and associated spasm of the bowel, and can betreated by anti-inflammatory agents (such as mesalamine), theobstruction can become chronic and cause scarring, luminal narrowing,and stricture formation, which require more serious intervention. PCDmay also cause sores or ulcers that tunnel through the affected areainto surrounding tissues, such as the bladder, vagina, or skin(enteroenteral, enterovesical, enterovaginal, or enterocutaneousfistulization). The fistulas in PCD patients often become infected andmust be treated with antibiotics or surgery.

PCD patients also commonly have nutritional complications, such asprotein, caloric, and vitamin deficiencies. These complications may becaused by inadequate dietary intake, intestinal loss of protein, ormalabsorption resulting from the underlying disease. Other complicationsassociated with PCD include arthritis, skin problems, inflammation inthe eyes or mouth, kidney stones, gallstones, or other hepaticconditions. PCD has important features that distinguish it from adultCrohn's disease, including growth retardation (usually attributed tosteroid therapy),¹ a high prevalence of osteopenia,¹ and several socialand psychological factors.¹

PCD's etiology is poorly understood, and is largely unknown. Thescientific literature postulates myriad causes, including genetic,microbial, immunologic, dietary, environmental, vascular, and evenpsychosocial factors. PCD affects males and females equally, but appearsto affect Caucasians more than other races, and the Jewish populationmore than other ethnic groups.

Unfortunately, there is no currently approved medication to cure PCD,and for some patients, intestinal surgery offers only a brief benefitbefore other areas of the intestine are affected again. There areseveral pharmacotherapeutic options that reduce PCD morbidity, preventcomplications, and maintain a patient's nutritional status.

Proposed Indication:

This orphan drug designation request is for Q101KC (levorotary aminoacids; essential fatty acids; collagen; vitamin/mineral/trace elementcomplex; probiotic complex) for the treatment of patients with PCD.

Reason for Therapy:

The current treatment options for PCD patients are less than optimal.While most available therapeutic options available to PCD patients arepalliative in nature, Q101KC stimulates the synthesis of protein andcell membrane formation in PCD patients. This, in turn, repairs thetissue in the affected areas and reduces inflammation, and, in effect,reverses the PCD disease process. Q101KC thus offers a therapeuticoption that is different from currently available options. Without suchan option, PCD patients are left with few options, including thepossibility of surgery and the lifetime use of potentially toxic drugs.

Product Composition and Formulation:

Q101KC includes five primary components: (1) levorotary amino acids; (2)a complex of essential fatty acids (consisting of phosphatidyl choline,omega 3 eicosapentaenoic acid (“EPA”), and docosahexaenoic acid(“DHA”)); (3) collagen; (4) a complex of vitamins, minerals, and traceelements of human tissue; and (5) a complex of probiotics (namelylactobacillus acidophilus, bifidobacterium bifidum, lactobacilisbulgaricus, and lactobacillus salivarius).

Rationale for the Use of Q101KC for the Treatment of Patients with PCD:

The rationale for the use of the three primary Q101KC components is tosynergistically stimulate the synthesis of protein and cell membraneformation in patients with PCD. In effect, Q101KC regenerates affected(inflamed) tissue so that it can no longer have the effects on the bodythat it would otherwise have. Because tissue is regenerated, the needfor anti-inflammatory intervention and/or surgery is significantlyreduced.

Component 1—Levorotary amino acids: to increase favor protein synthesisby altering the balance of free L amino acids.

Component 2—Essential fatty acids (e.g., phosphatidyl choline, EPA, andDHA): to correct cell membrane damage and to enhance the body'sproduction of anti-inflammatory prostaglandin 3 and prostaglandin 1.

Component 3—Collagen/ECM [extracellular matrix] components: to stimulatethe immune system and for tissue repair and anti-inflammatoryanti-neogenesis.

Component 4—Vitamin/Mineral/Trace element complex: to stimulate tissuerepair blocked by the underlying disease.

Component 5—Probiotic complex: to normalize abnormal microflora, tissue,and secretions.

Clinical Experience

Clinical experience with the components of Q101KC demonstrates that thisproduct can safely and effectively treat patients with PCD.

Components 1 & 4—Levorotary amino acids & Vitamin/Mineral/Trace elementcomplex

Several articles¹⁻¹⁰ show that elemental diets reversed growth failure,increased weight in children with Crohn's disease, and generally actedto reverse the symptoms of Crohn's disease comparable to steroid-treatedpatients resulting in significant clinical improvement.

Component 2—Essential fatty acids (e.g., phosphatidyl choline, EPA, andDHA)

Several articles—¹⁻⁴ show that essential fatty acids administered toCrohn's patients are an effective treatment for chronic inflammatorydisorders such as PCD. Essential fatty acids reverse the inflammatoryprocess and have been shown to maintain periods of Crohn's diseaseremission.

Component 3—Collagen/ECM [extracellular matrix] components:

Published literature¹⁻⁴ shows that collagen acts as an anti-inflammatoryand repairs damaged tissue. Using collagen to treat patients with PCDshould have similar effects and would also serve to wean patients off ofthe use of potentially toxic drugs.

Component 5—Probiotic complex

Bleichner, et al.¹ concluded that Saccharomyces boulardii preventeddiarrhea in certain critically ill patients with risk factors fordiarrhea, such a PCD. It is reasonable to conclude that other probioticswould have similar effects on PCD patients.

PCD, like Crohn's disease, is a type of inflammatory bowel disease(“IBD”). It is our understanding that FDA's Office of Orphan ProductsDevelopment recognizes PCD as a distinct disease. Nonetheless, we notethat Q101KC is specifically formulated for use in pediatric patients.Furthermore, the various side effects of current therapies (especiallysteroids, which have been attributed to growth retardation unique topediatric patients and osteopenia) means that PCD patients require atreatment option without such significant side effects, like Q101KC.

Size of Patient Population

Although there is some variation among the published literature as tothe precise prevalence of PCD, it is recognized as an orphan condition.In fact, In January 2003, FDA designated Alimentary Health Limited'sbifidobacterium longum infantis for the treatment of PCD. The followingprevalence figures are calculated using a United States populationestimate of 288,368,698 residents (of which 81,022,584 are zero to 19years old), as reported by the United States Census Bureau on Jul. 1,2002.¹

-   -   Cosgrove²⁴ reported an incidence of PCD in South Glamorgan,        United Kingdom of 16.6 per 100,000 children under 16 years old.        Although these data are from the UK, the population of the UK is        presumably similar to that of the United States. As such,        Cosgrove's incidence figure is relevant to calculating the        prevalence of PCD in the United States. Using Cosgrove's        incidence of 16.6 per 100,000 children and using an estimated        United States juvenile population of 81,022,584, the prevalence        of PCD in the United States is estimated to be 13,450.    -   Hildebrand et al.²⁵ reported an incidence of 21.5 per 100,000        children under 16 years old with IBD, including incidence        figures of 2.7 per 100,000 for PCD and probable PCD, in a study        conducted in southwestern Sweden. As with Cosgrove, the        Hildebrand study was not conducted in the United States.        Nonetheless, the study population may be representative of PCD        in the United States. Assuming that all 2.7 per 100,000 children        have PCD, and using an estimated United States juvenile        population of 81,022,584, the prevalence of PCD in the United        States is estimated to be 2,188. Even assuming that all 21.5 per        100,000 IBD children have PCD, and applying this incidence        figure to an estimated United States juvenile population of        81,022,584, the prevalence of PCD in the United States is        estimated to be 62,524.

Pharmacology and pharmacodynamic rationale sourcing of Q101 KC forCrohn's disease and Pediatric Crohn's disease (Patent Pending). So thatthe physician and health care professional can thereby logically andphysiologically derive therapy.

Q101KC:

The bio-science of this new drug discovery is based upon a series ofpatent pending non-covalently bonded inventions serving as a Q100 KCtherapeutics of CD (Crohn's Disease) As seen here, particularlyimportant in a chronic disease such as Crohn's, as well as wound healingand tissue regeneration represent an integral part of inflammation(separated only heretofore didactically); while the same usingcomponents that are also crucial for providing molecular embryonicdevelopment therefore also serving as stem cell repair kit.

In the application of molecular embryology metabolic factors and enzymesmaybe sourced at equivalent in this new drug discovery technology stageof animal development. This sourcing further corresponds to embryologicand molecular embryology and human embryologic development.

Therefore, while keeping with developmental inducing stem cell activityalong with the genetic code (all sourced from non-human tissue, medicalfood sources) as plant or animal tissue derived biochemicals analog andbio-chemically equivalent to human tissue sourcing of Q101 KC is inaccordance with GRAS code of federal regulations CFR21 all makingpossible foregoing file patent pending application of a newbio-scientific periodic table sourcing for new drug discover (In sharpcontrast to covalently bonded elements of Mendeleev's periodic tablerequiring years to decades of trial and perfection, economic challengethat is not possible for major companies and the public to meet).Medically as well as economically advantageous: in that this gentleapproach results in new medication with note worthy absence of sideeffects—bio safety companion to bio efficacy.

This molecular basis of therapeutics of disease such as Crohn's diseasedeveloped as a new patent pending cost worthy drug discovery technologynot only featuring non-covalent bonding whose effects are synergistic tothe electrostatic charged particle potential of colloid therapeuticdomain.

Component Nos. 1 and 2 are of small molecular composition, Component No.3 primarily of large molecular composition representing approximately10% of Q101 KC (70% a absorbed intact) Component No. 3 ECM. Thedevelopment and sourcing of components of this CD therapy are alwaysconformant to the genetic code, mimicking human tissue in it's structureand function (ECM post translational modifications) and are alsorepresented here as a progressive series of in utero organ tissuemolecular embryologic developments with stem cell inducing activities.

All the foregoing new drug development such as Q101KC therapeutics of CDpermit the facilitating, accelerating and synergizing the healing andtissue regeneration. Therefore reestablishing disease tissue to normalhuman tissue in accord with the intact colloidal domain of all tissuesfrom the ECM (Extracellular Matrix). The proteoglycans complex bindinglarge amounts of water forming a viscous hydrate gel which givesconnective tissue ability to resist compression therefore resilience andlubricity and associated electrostatic charge resulting in increasetensile strength of disease tissue and wound healing by 48%, ComponentNo. 3 as provided in shark cartilage 0.74 gram/capsule also includescollagen and chondroitin sulfate as 5 capsules 3.7 grams BID to TOcartilade, Fairfield, N.J.

The same advantages are endowed in the emulsion technology features ofcomponents 1, 2 and lipid anchor of glypicans of Component No. 3 ECMproteoglycans complex, being part lipid, which impede electricalconduction these components are also signaling systems (semiconductors)further normalizing human tissue they significantly counter the lipidprostaglandin's most profound inflammatory mechanism mediator viaComponent No. 2 while simultaneously and synergistically providingtissue healing and tissue regeneration. Wherein, Component No. 2 alsoprovided for cell membrane regeneration in addition to the healing ofcell membrane aided by the glycine amino acid Component of No. 1. WhileComponent No. 1 encompasses the 20 alpha amino acids of the humangenetic code provided for tissue protein formation which is soimperative in the healing process.

(The liquid crystal of all these foregoing components of emulsiontechnology aid in their liquid crystal alignment effects in the healingof diseased tissue as in CD. Exemplified by the chiral liquid crystalsComponent No. 1 who's living polymerization result in the formation ofnormal tissue protein in the healing process can be seen to be analogueto the synthesis of synthetic fabrics such as nylon*. These syntheticfabrics are made from liquid crystals that are also synergized by thelaw of mass action). These liquid crystals polymerize as syntheticfibers. This has been referred to as living polymerization beinganalogue to protein synthesis in human tissue.

Component No. 2 in a similar robotic like action provides for theproduction and reproduction of new cell membrane in disease tissue byself vesiculation of PC** (phosphatidyl choline) along with alsoproviding cell membrane focused omega 3 antiprostiglandin Component No.2 additional potent anti-inflammatory factors. Remarkably and unique tothis new drug discovery technology and Q101 KC as the gel hydrate of thecolloidal domain Component Nos. 1 and 2 and part of Component No. 3 ofemulsion technology with its lipid cell membrane anchor glypicans aresimilarly effectual in tissue regeneration and healing. These componentsare dependent mathematically upon calculation and ratio molecular lengthexpressed as I representing molecular length C2 to C6 in Component No. 1and C16 to C18 in Component No. 2 and volume of this lipid surfactantcomponent expressed as v for volume of this lipid moiety versus thissurfactant hydrophilic head group area expressed as ao with a formula Nsthe surfactant packing parameter=ao/v1. This may also be expressed asHLB hydrophilic lipophilic ratio. In fact the HLB of all these newmedication discoveries may require additional HLB modulation with highHLB surfactants 0.25°/a to ½% to 1% of such as sodium lauryl sulfate orpolysorbate 80 (Tween 80) have been found to reduce pathogenicpotential. Additionally in correlation again in reduction of pathogenicpotential the 3D geometry of the charged particle as measured by X Raydiffraction, NMR (with it's 30,000 molecular weight limitation) may becorrelated with polarizing light microscopy and further correlated withhistopathologic findings in other successful new product developments asmeasured by reversal to normal of pathogenicity further correlated withsuccessful in-vitro models computer disease and therapeutic computerresponse models may also be developed.

The integrated self help synergy of these components can be seen inglycine of Component No. 1 which can also patch a 100 angstrom diseasedcell membrane holes correcting these diseased induced lesions. Thisfurther illustrates the robotic self assembly* of tissue protein* in theearly stages of molecular embryology while awaiting DNA polymeraseformation as well as DNA, RNA and Ribosome formation.

Additionally the first stimulant of L-amino acid glycine resulting inthe first initiation of protein synthesis occurs in the ovum 15 minutesafter fertilization by the sperm (also referred to as the stem cell)through the release of phospholipase A2 resulting in the proteinsynthesis stimulant lysolecithin formation. Therefore lysolecithinrequires the substrate PC** of Component No. 2 phospholipase A2 also maybe utilized in the enzymatic portion of Component No. 5. Theanti-inflammatory tissue healing non-covalently bonding associated withincrease in electrostatic potential particle charge of the colloidaldomain all mimicking normal human tissue in structure and function allsingularly and synergistically unique to the anti-inflammatory family ofmedications. The electrostatic potential particle charge is readilymeasured with zetameter as zetapotential and adds to vital measurementsof human tissue vitality.

In CD a disease with genetic predisposition the medical food Q101KCtherapeutic composition comprising Component Nos. 1, 2 and 3 permit thegenomic DNA expansion by as much as ⅓rd thereby normalizing the genomicexpression. All mediated in directly through the patients own existingDNA. Thereby normalizing and expanding the DNA genomic expression. Thisconcept has been hypothesized and the hypothesis has been based onpre-clinical observations, but not taught in the prior art in thetherapeutics of patients as with CD. This genetic response without thedirect use of DNA as a therapeutic agent was stressed as a first timepatent pending multi center study along with product claims. Further itwas noted that patients found to stop Component No. 1 (#2) after 1 monthwere found to have no CD flare ups for 6 months. Additionally only 30%of these patients had flare ups even though no medication was taken forone year.

Q100 KC is also formulated to reduce mortality risk up to 90% bypreventing the greatest CD complication sepsis. CD sepsis is secondaryto translocation of the enteric bacterial flora such as E. coli. Thismorbidity and mortality therapeutic effect is coordinated and integratedin Component No. 4 through the administration of Riboflavin B2 50-100 mgin a balanced B 50 complex formulation. Synergistically combining thebalanced B complex beneficial effects along with the replacement in CDof poorly absorbed B12 with 500-1000 mcg. Pathophysiology the primarysite of B12 absorption is in the ileum. Because of the inflammation themucosal damage of the ileum B12 absorption is blunted and must besupplemented here.

B2 is an antioxidant and added to antioxidants as 1-2 grams of absorbicacid; 200 to 400 units of vitamin E as d-alpha Tocopherol, 5000 to10,000 units vitamin A as Beta-carotene, up to 200 mcg of Selenium andZinc 15 mg as in embodiment case report #3 in therapeutic subjectcomposition Component No. 4.

Another case example of a gentle, side effect free, economic drugdiscovery derived from this new drug discovery technology and newperiodic table. Case #1 is being treated for gout. Patient is intolerantto cyclo-oxygenase Cox 1 anti-inflammatory drugs such as ASA even insmall dosages. Intolerant side effects of severe fatigue interfere withdaily activity. The patient was also found to be intolerant to Cox 2inhibitor Bextra 20 mgm unanticipated side effects was pyrosis of almost1 weeks duration whereas the antioxidant ascorbic acid as grams 16capsules'/gram each of time release ascorbic acid granules (Carlson Lab,Arlington Heights, Ill.). The time released granules was used avoidsimilar upper GI symptoms (family history of a bleeding ulcer) this 8gram course of ascorbic acid was repeated once or twice in 4-8 hrs wasassociated with complete relief of acute and severe gouty arthritissymptoms (uric acid blood levels of 8-10 g %). Such large dosages ofascorbic acid have been repeatedly reported as harmless.

Thereby this new drug discovery therapeutics for gout was again storedfrom medical foods and proves to be bio-safe, free of side effects andeconomically derived. This is in sharp contrast to such highly effectivebut high risk medications such as Allopurinol with such severe sideeffects that include a mortality risk. This risk is particularlypertinent in patients such as case#1 with multiple severe drug reactionsthat threaten vital organs such false lupus drug reactions.

Uric acid is a anti-oxidant that is replaced by the innocuousantioxidant ascorbic acid.

The anti-oxidant ascorbic acid can be synthesized by the animal kingdomwhere as the anti-oxidant in uric acid is not present in animals helpfulcomparative biology in drug development.

The bio-science of this new drug discovery as a medical food on firstglance Q101 KC appears as 5 building blocks on closer review we insteadnow see 5 gemstones. Carefully and individually selected, hewn andpolished, presented and displayed here as a magnificent therapeuticmosaic converting CD from its formally recalcitrant recurrent clinicalpresentation as a disease with life threatening flare ups and guardedprognosis. Thereby also countering the interference with activities ofdaily living e.g. pediatric Crohn's disease, growth retardation andpuberty delay all additionally responsive to the therapeutic effectsQ101KC and its components.

Expanding the Clinical Application Efficacy of Subject CompositionCrohn's Disease Therapy to the Major Intestinal Diseases.

Expanding the clinical application efficacy of subject compositionCrohn's disease therapy to the major intestinal disease extensiveclinical research has been carried out. This research was based on 5component subject composition therapy of Crohn's Disease andPharmaco-dynamic rationale further details (enclosed in severalembodiments). To broaden comparative clinical applicability of thisresearch, similar research was performed regarding the following mostcommon intestinal diseases:

Diverticulitis: a very common disease in the elderly affecting ⅓ ofpeople in their 60's and more than ½ of people in their 80's. IrritableBowel Syndrome. The Inflammatory Bowel diseases: Crohn's Disease andUlcerative Colitis affects 1 million people. Bowel Cancer is a commoncomplication of Ulcerative Colitis. Bowel Cancer and Cancer were alsoincluded is this comparative disease review. This review includes 14 to25 nutritional components. Statistically significant observation wasmade in this review of medical foods nutritional components in theessential category.

Therapeutic Component No. 4 Balanced B50 with 50 mgm each of: Thiamine,Riboflavin, Folic Acid 400 mcg, vitamin B12 50 mcg, Biotin 50 mcg waslisted 5 of 6× (balanced B Complex also stressing here folic acids andvitamin B12).

Therapeutic Component No. 5 was listed 4 of 6× (a clinical firstrequirement in Crohn's Disease based on my further clinical experiencealso in this nutritional medical foods overview.

Therapeutic Component Nos. 2 and 3 of 5 were classified essential.

The prior art has not distilled a final therapeutic composition of 3 or5 components. The use of these components synergistically praticalizesand maximizes medical food compliance in this therapeutic composition

All 5 were listed across the board if the desirable or helpfulcategories were added with 1 single component omission in Diverticulitisand Crohn's of therapeutic Component No. 3. These 2 diseases with theabsence of therapeutic Component No. 3 indicates that these 3 or 5therapeutic subject composition components embodiments are not in theprior art.

Therapeutic Component No. 4 listed in Bowel Cancer with pre-clinicaldose related protection in Bowel Cancer, ascribed primarily to folicacid 400 mcg in cancer. Clinically cancer prevention the folic acidmaybe further synergized with the added protection of balanced Bcomplex. All these B complex components are 50 to 100 mgm Thiamine,Riboflavin, Niacin, B6. Pantothenic Acid, Folic Acid 400-800 mcg, B1212.5-25 meg and Biotin 500-100 mcg. This anti-cancer treatment increasedfolic acid 2-3 fold.

The balanced formulation prevents an increase in 1 or 2 of vitaminB-Complex components such as B6, folic acid or B12* from resulting in aparadoxical reduction of other B-Complex members such as B2 Riboflavinwhich is also an antioxidant.

Coenzymes involved primarily in mediating and providing activation ofturning on the metabolic ignition switch” of the amino acids as intherapeutic Component No. 1 and the metabolism of these amino acids andor nucleotides. These cofactors include: 1. Pyridoxal phosphates thecofactor for transamination and many other reactions of amino acidmetabolism, 2. Folic acid contains the amino acid glutamine (as inComponent No. 1) and may contain multiple glutamate residues as intriglutamate as in pteroyl gamma triglutamate, coenzymes which transfersingle-carbon functional groups in synthesizing nucleotides and certainamino acids. 3. The B12 or cobalamin, coenzymes which participate in thesynthesis of methionine in-vivo. Therefore it is not unexpected in thetreatment of Crohn's Disease there factors take therapeuticpre-eminence.

Therapeutic rationale the inflamed ileum of Crohn's Disease (the normalsite of B12 absorption is the ileum) In ileitis because of the inflamedileum this vitamin B12 absorption is blunted. Therefore, 500-1000 mgm ofB12 should be here prescribed. In the case report embodiment oraladministration concurrent with IN. antibiotics for E. coli sepsis thisbalance B complex therapy was used. The use was prompted by the findingsof a inflamed magenta red tongue which resulted from the large IVantibiotic dosage required for E. Coli sepsis which suppressed thesymbiotic bowel flora. It was noticed clinically within 1 hour of theuse of the balanced B complex the severe weakness from sepsis and thepost-operative state greatly improved clinically. This treatment wasmaintained for more than 6 weeks post operatively. The glossitispromptly cleared. A correlation was found in pre-clinical animal data ofdecreased mortality by 90% with use of IV Riboflavin B2 in these E. colisepsis mice. This was reported in the Japanese literature in March 2004.This balance B2 treatment fits well in the treatment of colitis andenteritis (small bowel) as a group where disease changes of mucosa canbring on increased morbidity and mortality risks due to translocation ofbacteria such as E. coli with resulting sepsis.

Also as we inspect the formula of folic acid we find a similar but lessextensive polymer of a highly hydrophilic amino acid with HLB of 15 to16 mL-glutamine coupled with lipophilic pteridine nucleus similar topyridine and lipophilic PABA-para-amino benzoic acid. In this regardfolic acid is analog to Tween 80 HLB 16 in vitro to normalized in vitrobreast cancer tissue functioning as an anti-cancer therapy. Usingclinically 5×s the concentration of P.C. with HLB 10 to 11 efficacy ofTween 80 0.25% was achieved. This 1.2% P.C. was used in conjunction withessential lipids as 20% soy bean oil. 500 cc of this formulation wasused IN. daily x5 for 5 days in cancer patient care. Excellent clinicalresponse was achieved with such mild measures in cancer with a very pooroutlook (squamous cell cancer of the tonsil). This is a very encouragingresult in a disease so resistant to the most high risk chemotherapeuticand radiation measures.

Cardiovascular application of therapeutic Component No. 2 Omega 3 fishoil, essential fatty acid fats provides a natural statin effect with itssignificant anti-inflammatory activity so important in counteringatherosclerosis. This is exemplified in other embodiments. Alsoclinically demonstrated by a 30% reduction in blood cholesterol levelsin a 60 year old male. This patient responded to Omega 3 fish oil EPA350 mg and DHA 250 mg of a total of 750 mg of fish oil Omega 3phospholipids in a 2 gram capsular dosage (Carlson Lab, ArlingtonHeights, Ill.) whose blood cholesterol was 150′/a mg pretreatment. Thiswas reduced to 110 mgm % without any risk of muscle weakness as withstatins, with further added advantage of prevention of fatal arthythemia(dysrhythmia) as documented by Leaf pre-clinically J. Clinical Nutrition2003.

Neurologic application The P.S. (phosphatidylserine) is the neurologicequivalent of P.C. (phosphatidylcholine) therapeutic Component No. 2P.S. 100-300 mgm TID and P.C. in lecithin or purified P.C. 0.9 g or 45%powered lecithin (both American Lecithin products, Oxford Conn.) with 1to 2 grams TID coupled with Omega 3 essential fatty acid fats both EPAand DHA 2 grams BID as 2 capsules 2× daily derived from northern salmonfrom deep cold waters of Norway salmon as used above as statinequivalent. This subject composition stain equivalent is analog tostatins. As statins have anti-inflammatory effects as ASA, theytherefore have been shown to have significant ant Alzheimer effect.Therefore, the scientific rationale for using all the foregoing threecomponents (or optionally P.S. and Omega 3 essential fatty acid) oftherapeutic Component No. 2 as anti-Alzheimer therapy. Such proteinmolecule normalization such as high HLB Tween 80 in prior embodimentsmay be utilized the abnormal beta sheet amyloid protein (in contrast tothe normal neural alpha helix random coil protein) of Alzheimer's andjoin the foregoing components as synergistic anti-Alzheimer's Therapy.Therefore this therapeutic regime must be considered in counteringsuspected contributory or causative factors of Alzheimer's disease. Aswell as Parkinson's disease, mad cow disease and its human equivalentand ALS.

The balance B complex and particularly folic acid and B6 and 1312 alsoas the amino acids of Component No. 1 cofactors provide coenzyme Nmetabolism. Also these B vitamin coenzymes also function as chelationagent as the non D-amino acids Component No. 1. Component Nos. 1 and (1& 2) as in Neocate 10 to 25 grams non D-amino acids of genetic code suchas human tissue such as stem cell such as Neocate infant formulas SHSNorth America, Liverpool, UK (#1&2) serving as a synthetic stem cellsubject composition. Also serving as chelating regarding potentialsuspected toxic metals as aluminum and or mercury. Therefore, atherapeutic rationale for inclusion as in anti-Alzheimer managementjoining the foregoing 2 or 3 components of therapeutic Component No. 2.

These Nitrogen metabolism coenzymes are also surfactant particularly theL-glutamine of the folic acid residue is analog to the hydrophilic HLB16 of Tween 80. Also hydrophilic HLB Tween 80 analog to polymerizedglutamine of the triglutimate folic acid residue suggestive of an HLB ofabout 15 to 16. This HLB can be more persistently determined by the useof DuNuoys tensionmeter and the HLB can thereby be calculated. P.C.contain phosphocholine has an HLB of 10-11 is also hydrophilic (beingabove 7 to 8) with phosphocholine serving as an analog surfactantcomponent of B6 pyridoxal phosphate. The therapeutic rationale for thesesurfactant components serving as a anti-cancer mechanism.

Additional New Drug Discovery Principles

Histopathologic changes with pathologic stains such H & E (hematoxylinand eosin) identification are highly dependant on the HLB index.Exemplified by lipophilicity H staining the hydrophobic nucleus, andeosin staining the hydrophilic cytoplasm. Therefore these staining HLBcharacteristics serve as the histopathologic guide to the foci of newdrug discovery. Wherein therapeutic Component No. 1 is applicable totissue protein healing and anti-inflammatory effects with Component No.1 glycine patching cell membrane disease damage as great as 100 Angstromunits. Therapeutic Component No. 2 heals cell membrane as P.C. (selfvesiculating robotic cell membrane formation) with therapeutic HLBflexibility. Component No. 3 ECM extra cellular matrix therapeutic toECM with anti-neo angiogenetic, anti-inflammatory, anti cancer, andtherapeutic activity. Therapeutic Component No. 4 normalizes Nmetabolism of protein and DNA. Therapeutic Component No. 5 normalizescell surface disease such as but not limited to such broad applicabilityto the intestinal diseases and associated intestinal mucosal surfacedamage as illustrated in foregoing embodiments.

To maximize hydration in this colloidal domain and emulsion technologydomain it is recommended that 6 to 8 glasses of water be consumed dailywith the utilization of therapeutic subject compositions.

Using this pathophysiology as the mechanical principles of cell andtissue repair in the management of disease the physician now throughthese modalities can better provide rationale based therapeutics throughsubject composition Cellbiochem Stem Cell Repair Kit™, Serial number forTrademark Application 76/573,604.

An anabolic composition is also provided, which comprises at least oneamino acid, at least one extracellular matrix compound, and at least onesurfactant, wherein the concentration of surfactant in the compositionis about 1% or greater with respect to the total composition. Allpercentages disclosed herein refer either to weight to volume (if aliquid composition) or weight to weight (if a solid composition).

Any biocompatible surfactant can be used in the composition. Suchsurfactants are known to those of skill in the art, and representativeexamples are included in Table 1 below. In addition to the surfactantslisted in Table 1, suitable surfactants for use in the compositioninclude lipids (for example phospholipids such as phosphatidylcholine,phosphatidylserine, phosphatidylinositol, phosphatidylethanolamine,phosphatidic acid and phosphotidyl glycerol); essential lipids (whichcan contain linoleic and linolenic acids), DHA, EPA, sphingolipids;sphingomyelin; glycolipids; cerebrosides; gangliosides; cephalin;lipovitellin; glycosphingolipids; and combinations thereof,monoglycerides, diglycerides, lipoproteins; polyglycerol polyricinolate;polysorbate 80; polysorbate 65 and sodium lauryl sulfate; andcombinations thereof.

The total amount of surfactant present in the composition can be in anamount of about 1% or greater; for example between about 1.2% and about20%. Suitable amounts of surfactant in the composition include about1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about1.8%, about 1.9%, about 2%, about 3%, about 4%, about 5%, about 6%,about 7%, about 7.5%, about 8%, about 9%, about 10%, about 11%, about12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%,about 19%, about 20%. Amounts of surfactant greater than about 20%(e.g., about 25%, about 30%, about 35%, about 40%, about 45% or about50%) are contemplated.

In some embodiments, the composition can comprise phosphotidylcholine inamounts of about 19% (to mimic human red blood cell membrane), about 10%(to mimic myelin membrane), about 39% (to mimic heart mitochondrialmembrane). In some embodiments, the composition can comprisephosphotidylethanolamine in amounts of about 18% (to mimic human redblood cell membrane), about 20% (to mimic myelin membrane) and about 27%(to mimic heart mitochondrial membrane). In some embodiments, thecomposition can comprise phosphotidylinositol in amounts of about 1% (tomimic human red blood cell membrane), about 1% (to mimic myelinmembrane) and about 7% (to mimic heart mitochondrial membrane). In someembodiments, the composition can comprise phosphotidylserine in amountsof about 8% (to mimic human red blood cell membrane), about 8% (to mimicmyelin membrane) and about 0.5% (to mimic heart mitochondrial membrane).In some embodiments, the composition can comprise phosphotidylserine inamounts of about 18% (to mimic human red blood cell membrane), about 20%(to mimic myclin membrane) and about 27% (to mimic heart mitochondrialmembrane). In some embodiments, the composition can comprisesphingomyelin in amounts of about 17.5% (to mimic human red blood cellmembrane), about 8.5% (to mimic myelin membrane) and about 0% (to mimicheart mitochondrial membrane). In some embodiments, the composition cancomprise glycolipid in amounts of about 10% (to mimic human red bloodcell membrane), about 26% (to mimic myelin membrane) and about 0% (tomimic heart mitochondrial membrane). In some embodiments, thecomposition can comprise phosphatidic acid in amounts of about 1.5% (tomimic human red blood cell membrane), about 0.5% (to mimic myelinmembrane), about 0% (to mimic heart mitochondrial membrane). In someembodiments, the composition can comprise phosphotidylglycerol inamounts of about 0% (to mimic human red blood cell membrane), about 0%(to mimic myclin membrane), about 0% (to mimic heart mitochondrialmembrane). In contrast, the E. coli cell membrane has 0%phosphotidylcholine, 0% phosphotidylinositol, 0% phosphotidylserine, 0%sphingomyelin, 0% glycolipid, 0% phosphatidic acid, 18%phosphotidylglycerol and 65% phosphotidylethanolamine.

The at least one surfactant in the composition can havehydrophilic/lipophilic balance (“HLB”) of less than about six (e.g.,about 1, about 2, about 3, about 4, about 5), or an HLB of about six orgreater (e.g., about 7, about 8, about 9, about 10, about 11, about 12,about 13, about 14, about 15, about 16, about 17, about 18, about 19 orabout 20). In one embodiment, the surfactant has an HLB value of about13.

TABLE 1 Exemplary Surfactants Name MFR.* Chemical Designation Type†HLB†† Span 85 1 Sorbitan trioleate N 1.8 Arlacel 85 1 Sorbitan trioleateN 1.8 Atlas G-1706 1 Polyoxyethylene sorbitol beeswax N 2 derivativeSpan 85 1 Sorbitan tristearate N 2.1 Arlacel 65 1 Sorbitan tristearate N2.1 Atlas G-1050 1 Polyoxyethylene sorbitol N 2.6 hexastearate EmcolEO-50 2 Ethylene glycol fatty acid ester N 2.7 Emcol ES-50 2 Ethyleneglycol fatty acid ester N 2.7 Atlas G-1704 1 Polyoxyethylene sorbitolbeeswax N 3 derivative Emcol PO-50 2 Propylene glycol fatty acid ester N3.4 Atlas G-922 1 Propylene glycol monostearate N 3.4 “Pure” 6 Propyleneglycol monostearate N 3.4 Atlas G-2158 1 Propylene glycol monostearate N3.4 Emcol PS-50 2 Propylene glycol fatty acid ester N 3.4 Emcol EL-50 2Ethylene glycol fatty acid ester N 3.6 Emcol PP-50 2 Propylene glycolfatty acid ester N 3.7 Arlacel C 1 Sorbitan sesquioleate N 3.7 Arlacel83 1 Sorbitan sesquioleate N 3.7 Atlas G-2859 1 Polyoxyethylene sorbitol4.5 oleate N 3.7 Atmul 67 1 Glycerol monostearate N 3.8 Atmul 84 1Glycerol monostearate N 3.8 Tegin 515 5 Glycerol monostearate N 3.8 Aldo33 4 Glycerol monostearate N 3.8 “Pure” 6 Glycerol monostearate N 3.8Atlas G-1727 1 Polyoxyethylene sorbitol beeswax N 4 derivative EmcolPM-50 2 Propylene glycol fatty acid ester N 4.1 Span 80 1 Sorbitanmonooleate N 4.3 Arlacel 80 1 Sorbitan monooleate N 4.3 Atlas G-917 1Propylene glycol monolaurate N 4.5 Atlas G-3851 1 Propylene glycolmonolaurate N 4.5 Emcol PL-50 2 Propylene glycol fatty acid ester N 4.5Span 60 1 Sorbitan monostearate N 4.7 Arlacel 60 1 Sorbitan monostearateN 4.7 Atlas G-2139 1 Diethylene glycol monooleate N 4.7 Emcol DO-50 2Diethylene glycol fatty acid ester N 4.7 Atlas G-2146 1 Diethyleneglycol monostearate N 4.7 Emcol DS-50 2 Diethylene glycol fatty acidester N 4.7 Atlas G-1702 1 Polyoxyethylene sorbitol beeswax N 5derivative Emcol DP-50 2 Diethylene glycol fatty acid ester N 5.1 Aldo28 4 Glycerol monostearate A 5.5 (self-emulsifying) Tegin 5 Glycerolmonostearate A 5.5 (self-emulsifying) Emcol DM-50 2 Diethylene glycolfatty acid ester N 5.6 Atlas G-1725 1 Polyoxyethylene sorbitol beeswax N6 derivative Atlas G-2124 1 Diethylene glycol monolaurate N 6.1 (soapfree) Emcol DL-50 2 Diethylene glycol fatty acid ester N 6.1 Glaurin 4Diethylene glycol monolaurate N 6.5 (soap free) Span 40 1 Sorbitanmonopalmitate N 6.7 Arlacel 40 1 Sorbitan monopalmitate N 6.7 AtlasG-2242 1 Polyoxyethylene dioleate N 7.5 Atlas G-2147 1 Tetraethyleneglycol monostearate N 7.7 Atlas G-2140 1 Tetraethylene glycol monooleateN 7.7 Atlas G-2800 1 Polyoxypropylene mannitol dioleate N 8 Atlas G-14931 Polyoxyethylene sorbitol lanolin N 8 oleate derivative Atlas G-1425 1Polyoxyethylene sorbitol lanolin N 8 derivative Atlas G-3608 1Polyoxypropylene stearate N 8 Span 20 1 Sorbitan monolaurate N 8.6Arlacel 20 1 Sorbitan monolaurate N 8.6 Emulphor 3 Polyoxyethylene fattyacid N 9 VN-430 Atlas G-1734 1 Polyoxyethylene sorbitol beeswax N 9derivative Atlas G-2111 1 Polyoxyethylene oxypropylene N 9 oleate AtlasG-2125 1 Tetraethylene glycol monolaurate N 9.4 Brij 30 1Polyoxyethylene lauryl ether N 9.5 Tween 61 1 Polyoxyethylene sorbitan N9.6 monostearate Atlas G-2154 1 Hexaethylene glycol monostearate N 9.6Tween 81 1 Polyoxyethylene sorbitan N 10.0 monooleate Atlas G-1218 1Polyoxyethylene esters of mixed N 10.2 fatty and resin acids AtlasG-3806 1 Polyoxyethylene cetyl ether N 10.3 Tween 65 1 Polyoxyethylenesorbitan tristearate N 10.5 Atlas G-3705 1 Polyoxyethylene lauryl etherN 10.8 Tween 85 1 Polyoxyethylene sorbitan trioleate N 11 Atlas G-2116 1Polyoxyethylene oxypropylene N 11 oleate Atlas G-1790 1 Polyoxyethylenelanolin derivative N 11 Atlas G-2142 1 Polyoxyethylene monooleate N 11.1Myrj 45 1 Polyoxyethylene monostearate N 11.1 Atlas G-2141 1Polyoxyethylene monooleate N 11.4 P.E.G. 400 6 Polyoxyethylenemonooleate N 11.4 monooleate P.E.G. 400 7 Polyoxyethylene monooleate N11.4 monooleate Atlas G-2076 1 Polyoxyethylene monopalmitate N 11.6S-541 4 Polyoxyethylene monostearate N 11.6 P.E.G. 400 6 Polyoxyethylenemonostearate N 11.6 monostearate P.E.G. 400 7 Polyoxyethylenemonostearate N 11.6 monostearate Atlas G-3300 1 Alkyl aryl sultanate A11.7 Triethanolamine oleate A 12 Atlas G-2127 1 Polyoxyethylenemonolaurate N 12.8 Igepal CA-630 3 Polyoxyethylene alkyl phenol N 12.8Atlas G-1431 1 Polyoxyethylene sorbitol lanolin N 13 derivative AtlasG-1690 1 Polyoxyethylene alkyl aryl ether N 13 S-307 4 Polyoxyethylenemonolaurate N 13.1 P.E.G. 400 6 Polyoxyethylene monolaurate N 13.1monolaurate Atlas G-2133 1 Polyoxyethylene lauryl ether N 13.1 AtlasG-1794 1 Polyoxyethylene castor oil N 13.3 Emulphor 3 Polyoxyethylenevegetable oil N 13.3 EL-719 Tween 21 1 Polyoxyethylene sorbitan N 13.3monolaurate Renex 20 1 Polyoxyethylene esters of mixed N 13.5 fatty andresin acids Atlas G-1441 1 Polyoxyethylene sorbitol lanolin N 14derivative Atlas G-7596J 1 Polyoxyethylene sorbitan N 14.9 monolaurateTween 60 1 Polyoxyethylene sorbitan N 14.9 monostearate Tween 80 1Polyoxyethylene sorbitan N 15 monooleate Myrj 49 1 Polyoxyethylenemonostearate N 15.0 Atlas G-2144 1 Polyoxyethylene monooleate N 15.1Atlas G-3915 1 Polyoxyethylene oleyl ether N 15.3 Atlas G-3720 1Polyoxyethylene stearyl alcohol N 15.3 Atlas G-3920 1 Polyoxyethyleneoleyl alcohol N 15.4 Emulphor 3 Polyoxyethylene fatty alcohol N 15.4ON-870 Atlas G-2079 1 Polyoxyethylene glycol N 15.5 monopalmitate Tween40 1 Polyoxyethylene sorbitan N 15.6 monopalmitate Atlas G-3820 1Polyoxyethylene cetyl alcohol N 15.7 Atlas G-2162 1 Polyoxyethyleneoxypropylene N 15.7 stearate Atlas G-1471 1 Polyoxyethylene sorbitollanolin N 16 derivative Myrj 51 1 Polyoxyethylene monostearate N 16.0Atlas G-7596P 1 Polyoxyethylene sorbitan N 16.3 monolaurate Atlas G-21291 Polyoxyethylene monolaurate N 16.3 Atlas G-3930 1 Polyoxyethyleneoleyl ether N 16.6 Tween 20 1 Polyoxyethylene sorbitan N 16.7Monolaurate Brij 35 1 Polyoxyethylene lauryl ether N 16.9 Myrj 52 1Polyoxyethylene monostearate N 16.9 Myrj 53 1 Polyoxyethylenemonostearate N 17.9 Sodium oleate A 18 Atlas G-2159 1 Polyoxyethylenemonostearate N 18.8 Potassium oleate A 20 Atlas G-263 1 N-cetyl N-ethylmorpholinium C 25-30 ethosulfate Pure sodium lauryl sulfate A App. 40 *1= Atlas Powder Company, 2 = Emulsol Corporation, 3 = General Aniline &Film Corporation, 4 = Glyco Products Company, Inc., 5 = GoldschmidtChemical Corporation, 6 = Kessler Chemical Company, Inc., 7 = W. C.Hardesty Company, Inc. †A = Anionic, C = Cationic, N = Nonionic. ††HLBvalues, either calculated or determined, believed to be correct to ±1.

The composition can comprise one or more other components, such as aminoacids; extracellular matrix components; electrolytes, minerals, vitaminsor trace elements; and probiotics. In some embodiments, the compositioncan further comprise vitelloprotein.

Any amino acid or combination of amino acids can be used in thecomposition. For example, the 20 naturally-occurring L amino acids (andglycine, which has no stereospecificity) can be used, as theL-stereoisomer is what the mammalian body naturally makes and uses. TheL amino acids can be optically pure form. “Optically pure” as usedherein means having at least about 90% by weight of one stereoisomer andabout 10% by weight or less of one or more other stereoisomers. Forexample, the L amino acids can be at least about 95% by weight of the Lisomer and about 5% by weight or less of the D isomer, such as greaterthan about 99% by weight of the L isomer and about 1% or less by weightof the D isomer. Optically pure L amino acids are commercially availableand are preferred, and also are readily obtainable by methods known tothose of skill in the art, for example, by synthesis from an opticallypure intermediate.

The amino acids used in the composition can comprise one or moreessential amino acids. As used herein, “essential amino acids” are thoseamino acids that must be supplied in the diet because an organism cannotsynthesize sufficient quantities of them. Essential amino acids foradult humans are arginine, histidine, isoleucine, leucine, lysine,methionine, threonine, tryptophan, and valine. Essential amino acids forother groups of human patients or other organisms are known to those ofskill in the art.

The amino acids used in the composition can comprise one or more freeamino acids, or can be supplied as part of a peptide or protein. As usedherein, “free amino acids” are those amino acids that are not part of apeptide or a protein. Free amino acids can be in acid or salt form.

Amino acids for use in the composition can be derived from naturalsources or can be synthetically produced. Suppliers of suitable aminoacids include Ajinomoto USA of Torrance, Calif. and Tanabe USA Inc. ofSan Diego, Calif. One exemplary source of amino acids is Neocate®elemental diet, sold by SHS of Liverpool, UK, which contains inter aliaessential and non-essential amino acids, dried glucose syrup, fat,minerals, trace elements and vitamins.

The amount of amino acid(s) comprising the compositions can be thosedaily amounts recommended as an elemental diet for infants or otherssuffering from gastrointestinal problems. For example, the total aminoacid amount in the compositions can be less than about 20 grams, such asabout 15 grams or about 10 grains. A suitable amount of amino acid(s) inthe composition can comprise 1-2 grams amino acids administered as partof the composition three to four times daily, for a total amount ofthree to eight grams daily.

Greater or lesser amounts of amino acids in the composition arecontemplated, for example about 0.5 to about 0.9 grams daily.

Other suitable amino amounts comprising the composition can be withinthe following weight ranges, for daily administration:

L alanine: about 0.5 to about 12.5 grams, for example about 5 to about 9grams.

L arginine: about 0.05 to about 12.5 grams, for example about 1 to about9 grams.

L asparagine: about 0.05 to about 12.5 grams, for example about 0.5 toabout 9 grams.

L aspartic acid: about 0.05 to about 6 grams, for example about 0.5 toabout 6 grams.

L cysteine: about 0.1 to about 1 gram, for example about 0.5 to about 1gram.

L cystine: about 0.5 to about 12.5 grams, for example about 0.5 to about9 grams.

L glutamine: about 0.5 to about 12.5 grams, for example about 0.5 toabout 9 grams.

L glutamic acid: about 0.5 to about 6 grams.

Glycine: about 0.5 to about 12.5 grams, for example about 0.5 to about 9grams.

L histidine: about 0.5 to about 12.5 grams, for example about 0.5 toabout 9 grams.

L isoleucine: about 0.5 to about 12.5 grams, for example about 1 toabout 9 grams.

L leucine: about 0.5 to about 12.5 grams, for example about 0.5 to about5 grams.

L lysine: about 0.5 to about 12.5 grams, for example about 0.5 to about9 grams.

L methionine: about 0.5 to about 12.5 grams, for example about 0.5 toabout 9 grams.

L phenylalanine: about 0.5 to about 12.5 grains, for example about 0.5to about 9 grams.

L proline: about 0.5 to about 12.5 grams, for example about 1 to about 9grams.

L serine: about 0.5 to about 6 grams.

L threonine: about 0.5 to about 12.5 grams, for example about 0.5 toabout 9 grams.

L tryptophan: about 0.5 to about 6 grams.

L tyrosine: about 0.5 to about 12.5 grams, for example about 0.5 toabout 9 grams.

L valine: about 0.5 to about 5 grams, for example about 0.5 to about 3grams.

L taurine: about 0.5 to about 12.5 grams, for example about 0.5 to about9 grams.

L carnitine: about 0.5 to about 12.5 grams, for example about 0.5 toabout 9 grams.

The composition can also comprise one or more essential lipids inaddition to the surfactants discussed above. As used herein, “essentiallipids” are those lipids that must be supplied in the diet because anorganism cannot synthesize them in sufficient quantities. For mammals,the essential lipids include linoleic and linolenic acids. Essentiallipids for use in the composition can be obtained, for example, fromflaxseed, soy, safflower or sesame oils.

The composition can also comprise one or more extracellular matrixcomponents. Suitable extracellular matrix components includeglucosamines, glycosaminoglycans, collagens, cartilage, chondroitinsulfates, hyaluronic acid, hyaluronan mucopolysaccharides,glycoproteins, and proteoglycans. Where shark cartilage is used, thecomposition can comprise about 700 mg to about 2500 mg, for exampleabout 740 to about 1480 mg, administered 1, 2, 3, 4 or 5 times daily aspart of the total composition. Shark cartilage can be obtained in powderform, and typically contains cartilage with 12% chondroitin sulfate andcollagen. Suitable shark cartilage is sold under the name of Cartiladefrom BioTherapies, Inc., Fairfield N.J. Bovine cartilage can also beused, for example that which is available from Phoenix Biologics, Inc.(Vista, Calif.), such as administered in a dose of about 750 mgadministered 1, 2, 3, 4 or 5 times daily as part of the totalcomposition. Combinations of the shark and bovine cartilage can be used.When hyaluronic acid and hyaluronan mucopolysaccharides are used, thesource may be human umbilical cord tissue.

Other suitable extracellular components include glucosamine, which isbelieved to be incorporated into the body's mucopolysaccharides, andhyaluronic acid, chondroitin sulfate and nutrient substrate cartilage,available from many animals including cow, pig and chicken. Suitableamounts of glucosamine for use in the composition is about 0.5 grams toabout 1 gram, administered 3 times daily as part of the totalcomposition. A suitable amount of chondroitin sulfate is about 250 mg toabout 500 mg, for example 390 mg to 490 mg, administered 3 to 4 timesdaily as part of the total composition.

The composition can also comprise one more probiotics. Suitableprobiotics include a plurality of beneficial microorganisms (such aslactobacilli, acidophilus, and other yogurt cultures), enzymes, orcombinations thereof. Suitable probiotics also include any substancethat promotes the growth of beneficial microorganisms in the compositionor subject to which the composition is administered, either alone or incombination with other probiotics.

The composition can also comprise at least one electrolyte, vitamin,mineral or trace element. Suitable electrolytes include sodium,potassium and calcium, and can be present in the composition in aconcentration of between about 0.1% and about 50%, including anyfractional percentage in intervals of about 0.01%. For example, theelectrolyte (in particular, potassium) concentration can be representedas about “A.BC %,” where A is any integer selected from 0, 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41,42, 43, 44, 45, 46, 47, 48, 49 or 50; B is any integer selected from 0,1, 2, 3, 4, 5, 6, 7, 8, or 9; and C is any integer selected from 0, 1,2, 3, 4, 5, 6, 7, 8 or 9. Greater or lesser amounts of electrolytes foruse in the composition are contemplated. Suitable vitamins and mineralsinclude typical adult daily dosages, for example: Vitamin A (about 1000to about 10,000 IU; Vitamin B1 or thiamine (about 50 mg); Vitamin B2 orriboflavin (about 50 mg); Vitamin B3 as niacin or niacinamide (about 50to about 500 mg); Vitamin B5 or pantothenic acid (about 50 to about 100mg); Vitamin B6 or pyridoxine (about 50 m); Vitamin B12 (about 300 toabout 1000 mcg); Biotin (about 300 mcg); Choline (about 100 mg); Folicacid (about 800 mcg); Inositol (about 100 mg); Para-aminobenzoic acid(about 50 mg); Vitamin C (about 50 mg to about 3000 mg or more, inmultiple daily doses); Bioflavonoids (mixed—about 500 mg); Hesperidin(about 100 mg); Rutin (about 25 mg); Vitamin D (about 400 IU); Vitamin E(about 200 to about 600 IU); Vitamin K (about 100 mcg); Apatite (forexample microcrystalline hydroxyapaptite—about 4762 mcg; Chromium (about150 mcg); Copper (about 3 mg); Iodine (about 225 mcg); Iron (about 18mg); Magnesium (about 750 to about 1,000 mg); Manganese (about 10 mg);Molybdenum (about 30 mcg); Selenium (about 200 mg); and Zinc (about 50mg). Greater or lesser amounts of vitamins, minerals or trace elementsfor use in the composition are contemplated.

Thus, the anabolic composition can comprise a surfactant as describedabove, which can be combined with one or more of at least one aminoacid, at least one extracellular matrix compound, at least oneelectrolyte, vitamin, mineral or trace element; and at least oneprobiotic.

The composition can be formulated for oral, topical or parenteral use,for example as pharmaceutical formulations. A pharmaceutical formulationcomprises the composition and at least one pharmaceutically acceptableexcipient, carrier or additive. Suitable topical formulations includeointments, creams or lotions, eye ointments and eye or ear drops,impregnated dressings and aerosols, and can contain conventionalexcipients and additives such as preservatives, solvents to assist drugpenetration and emollients in ointments and creams. Topical formulationscan also comprise physiologically compatible carriers, such as cream orointment bases and ethanol or oleyl alcohol for lotions. Such carrierscan be present as from about 1% up to about 98% of the formulation, forexample up to about 80% of the formulation.

Oral formulations can be in the form of a compressed solid or dry powder(for example finely milled powder), which can optionally be mixed withwater or other suitable liquid vehicle before use. The biologicavailability of an oral formulation can be tested by placing theformulation to a vessel containing water or water and an acidic compound(such as 1-5% HCI or acetic acid) to confirm that the formulationdissolves partially or completely. Partial or complete dissolutionindicates good bioavailability. For parenteral administration, fluidformulations can be prepared utilizing the therapeutic formulations ofthe invention mixed with a sterile, pyrogen-free physiologicallyacceptable carrier or excipient, such as water or physiological saline.

Colorants, flavorants, viscosity modifiers and other additives commonlyused in preparing pharmaceutical or nutritional formulations can also beused, as are known to those of ordinary skill in the art. Formulationsof the composition can be readily made by those of ordinary skill in theart using standard techniques, for example as described in Remington'sPharmaceutical Science, 17th ed., Mack Publishing Company, Easton, Pa.(1985), the entire disclosure of which is herein incorporated byreference.

Thus, the composition can be administered by any oral or parenteralroute, for example by mouth, intrarectally, intranasally, by inhalationinto the lung, intravaginally, intravascularly (by infusion orinjection), intrapertioneally, intramuscularly and local administration(such as injection or deposition) in or around the tissue to be treated.

The composition can be used to treat patients suffering from (orsuspected to be suffering from) a variety of chronic diseases orconditions. For example, the composition can be administered to apatient suffering from, or suspected to be suffering from cancer. Thetypes of cancer that can be treated include cancers of at least thefollowing histologic subtypes: sarcoma (cancers of the connective andother tissue of mesodermal origin); melanoma (cancers deriving frompigmented melanocytes); carcinoma (cancers of epithelial origin);adenocarcinoma (cancers of glandular epithelial origin); cancers ofneural origin (glioma/glioblastoma and astrocytoma); and hematologicalneoplasias, such as leukemias and lymphomas (e.g., acute lymphoblasticleukemia and chronic myelocytic leukemia).

Types of cancers that can be treated with the composition also includecancers having their origin in any organ or tissue of the body, forexample, the following organs or tissues, regardless of histologicsubtype: breast; tissues of the male and female urogenital system (e.g.,ureter, bladder, prostate, testis, ovary, cervix, uterus, vagina); lung;tissues of the gastrointestinal system (e.g., stomach, large and smallintestine, colon, rectum); exocrine glands such as the pancreas andadrenals; tissues of the mouth and esophagus; brain and spinal cord;kidney (renal); pancreas; hepatobiliary system (e.g., liver, gallbladder); lymphatic system; smooth and striated muscle; bone and bonemarrow; skin; and tissues of the eye (e.g., retinoblastomas).

Types of cancers that can be treated with the composition also includecancers or tumors in any prognostic stage of development, for example asmeasured by the “Overall Stage Groupings” (also called “Roman Numeral”)or the “Tumor, Nodes, and Metastases” (TNM) staging systems. Appropriateprognostic staging systems and stage descriptions for a given cancer areknown in the art, for example as described in the National CancerInstitute's “CancerNet” Internet website.

An effective amount of the composition is administered to a patientsuffering from (or suspected to be suffering from) cancer. An effectiveamount is that amount of the composition which inhibits theproliferation of a cancer cell. As used herein, to “inhibit theproliferation of a cancer cell” means to kill a cancer or tumor cell, orpermanently or temporarily arrest the growth of the cell. Inhibition oftumor cell proliferation can be inferred if the number of tumor cells inthe subject remains constant or decreases after administration of thecomposition, or cancer cell cycles and the metabolic cycles ofassociated organelles (such as the mitochondria) are normalized. Aninhibition of cancer or tumor cell proliferation can also be inferred ifthe absolute number of such cells increases, but the rate of tumorgrowth decreases. The number of cancer cells in a subject's body can bedetermined by direct measurement, or by estimation from the size ofprimary or metastatic tumor masses. The size of a tumor mass and extentand location of metastasis can be ascertained, for example, by directvisual observation or by diagnostic imaging methods such as X-ray,magnetic resonance imaging, ultrasound, scintigraphy and PET scan. Suchdiagnostic imaging methods can be employed with or without contrastagents, as is known in the art. The size of a tumor mass can also beascertained by physical means, such as palpation of the mass ormeasurement of the mass with a measuring instrument such as a caliper.Ascertaining the size and location of tumors or metastases can also beused to direct the focal administration of the composition, for exampleby direct injection to or around the tumor or metastases.

An effective amount of the composition can also comprise that amountwhich stops the progression of, lessens or reverses any condition orsymptom associated with the cancer. For example, an effective amount cancomprise an amount of the composition sufficient to stop the progressionof, lessen or reverse cachexia and/or anorexia associated with a cancer(see, e.g., Examples 1 and 2 below). Indeed, an in vitro reversal ofbreast cancer of 76%-83% was observed after one week of intravenousadministration of the composition. The prognosis of a patient with headand neck cancer also improved greatly after one week intravenousinfusion of the composition. One skilled in the art can readilydetermine an effective amount of the composition to be administered to apatient, by taking into account factors such as the size and weight ofthe subject; the extent of the tumor growth or disease penetration; theage, health and sex of the subject; the route of administration; andwhether the administration is regional (e.g., local) or systemic.

One skilled in the art can also readily determine an appropriate dosageregimen for administering the composition to a patient. For example, thecomposition can be administered to the subject once, for example as asingle infusion or oral administration. Alternatively, the agent can beadministered multiple times, for example once, twice, thrice, four, fiveor six times daily to a patient for a period of from about three toabout twenty-eight days, such as from about seven to about fourteendays. In one dosage regimen, the agent is administered orally orparenterally three to four times weekly (or every other day), for threeto six months or for an indefinite time period to maintain therapeuticeffects.

The compositions can also be used to help reduce the risks of adversereactions associated with the use of certain allergenic plasticizers inrenal dialysis, and thereby prevent recurrent anaphylaxis in dialysisand ameliorate acute flareups. Furthermore, the compositions are usefulin reducing the risk of kidney or other organ or tissue transplantationrejections. Asthma may also be treated, as well as ailments of the GItract such as regional ileitis (Crohn's disease) and other inflammatorybowel diseases, including ulcerative colitis, mucous colitis, and liverdisease such as congenital biliary atresia. The composition isparticularly useful for treating inflammatory bowel diseases that areresistant to present therapies, and for treating inflammation such asthat associated with atherosclerosis (e.g., peripheral vascular disease)and complications of this, which can include threatened limb loss,gangrene, coronary artery disease, myocardial infarction, stroke orcerebral vascular accident. Further diseases that can be treated withthe composition include degenerative, congenital and hereditarydiseases, such as congenital aneurysm (Berry aneurysm).

The composition can be used also in the treatment of trauma anddeforming diseases, such as leprosy, and skin and nerve damage.Bacterial infections, such as drug resistant tuberculosis, chronicfatigue and muscle weakness can also be treated.

Diseases of the endoderm, ectoderm, mesoderm and mesenchymal surfacescan be treated with the composition. For example, diseases of theectodermal surfaces including skin, hair, nails and teeth are amenableto treatment by the compositions. In particular, eczema, urticaria andpsoriasis can be treated. The compositions can also accelerate healingand reduce the risks of corneal graft rejection.

The anabolic compositions can also reduce the effects of aging, forexample when the production of digestive enzymes and growth hormone isdiminished. The composition can also be used to treat immunopathies suchas milk allergies, colitis, and autoimmune diseases.

Furthermore, compositions can be used to treat AIDS patients, forexample those on anti-protease drugs. AIDS patients on conventionalanti-protease drugs often have extreme hyperlipidemia, with serumtriglyceride levels of 3,000 to 6,000 mg %. Thus, the anti-proteasemedication may need to be reduced or withdrawn to protect the heart andblood vessels from the medication's side-effects, such as coronaryartery disease. Administration of the composition to AIDS patients onanti-protease drugs can reduce the hyperlipidemia and minimize theundesirable side effects of the drug. As a result, anti-protease dosagescan be lessened while achieving the same therapeutic results.

Metabolic storage diseases, such as glycogen storage diseases lipidstorage disorder, and demyelinating diseases (such as multiple sclerosisand Pelizeus-Merzbacher disease) can also be treated with thecomposition, as well as disorders of the blood-brain barrier andneurological diseases (e.g., rabies) and meningitis. Degenerativeneurological diseases such as ALS, pernicious anemia, Alzhiemer'sdisease, Huntington's chorea, and prion-based diseases such asKreutzfleld-Jacob disease can also be treated with the composition. Thecomposition can be used for preventive treatment of the diseases andconditions discussed herein.

For the diseases discussed above, the patient is administered aneffective amount of the composition. An effective amount of thecomposition can also comprise that amount which stops the progressionof, lessens or reverses any condition or symptom associated with thedisease. For example, an effective amount can comprise an amount of thecomposition sufficient to stop the progression of, lessen or reverseinflammation associated with an inflammatory bowel disease. One skilledin the art can readily determine an effective amount of the compositionto be administered to a patient, by taking into account factors such asthe size and weight of the subject; the extent of disease penetration;the age, health and sex of the subject; the route of administration; andwhether the administration is regional (e.g., local) or systemic. Dosageroutes and dosage regimens are as described above for treatment ofcancer.

Without being bound to any theory, it is thought that the essentialcomponents of the composition promote favorable substrate nutrition invivo as well as in vitro for stem cells to thrive and participate intissue repair, replacement and regeneration. Such effects may occur inmesodermal and mesenchymal tissue, as well as endodermal surfaces suchas the gut lining and respiratory tract.

Furthermore, but without wishing to be bound by any theory, thesimultaneous administration of components of the therapeuticformulations is believed to work synergistically to promote tissuehealing at higher levels and at a more rapid speed than if thecomponents were administered individually at different times.

Again without wishing to be bound by any theory, it is believed that byadministering the therapeutic formulations of the present invention andavoiding or minimizing ingestion of foods containing microorganismmetabolites or catabolic products (such as dairy products), thepatient's recovery is enhanced because the gastrointestinal tract willonly be minimally occupied in proteolysis of exogenous proteins and willstill serve its immune-like functions, such as control microorganisms(an antibiotic-like function), elimination of viruses, and aiding in therepair of injured tissue to permit tissue healing through the supply ofadequate nutrients.

Alternatively, and again without wishing to be bound by any theory, thecomposition provides nutrition to non-neoplastic cells of the patient,while depriving neoplastic cells of their primary nutrition source.Thus, the composition is advantageously used to combat thecachexia/anorexia syndrome so often seen in cancer patients.

EXAMPLES

The following examples are used to illustrate preferred embodiments ofthe invention and are not meant to limit the scope of the invention inany way.

In medicine, the average dosages are determined from a bell-curve. Forexample, most of the patients might respond to dosages as given.However, the beginning of the bell curve response might be 10% to 50% ofthese dosages and the end of the bell curve might be 125% to 200% ofthese dosages. Further results may be augmented by addition of componentNo. 4 and No. 5 to compositions comprising components Nos. 1-3. Inaddition, this provision applies to all examples included by referenceof Patent Ser. Nos. 60/149,338, Ser. No. 09/639,859, 10/752,298, and10/765,664.

Example 1 Example of Multi-Center Study

Within three to six weeks of initiation of this treatment using thecompositions of the invention approaching 95% of Crohn's disease (CD)and pediatric Crohn's disease (PCD) patients are being studied indouble-blind, placebo-controlled multi-center including 35radiographically tagged inflammatory neutrophile permeability studies aswell as the open study are able to discontinue the immune suppressiontherapy.

Remarkably, the discontinuance is not associated with relapse for aperiod of at least six months. More than 95% are maintained in thedisease-free state for as long as one year. Growth arrest and pubertysuppression are overcome within six weeks in more than 20 patients witha predictable efficacy of over 95% in 150 patients (⅓ of 450 beingstudied, (PCD cases treated exceed 200 patients). Controlled in-vitrotissue culture studies of biopsied Crohn's tissue evidences significant(approaching more than 95%) reduction in inflammatory mediatorchemokines relative to controls after 24 hours.

The compositions also avert the need for surgery to address anotherCrohn's Disease complication (intestinal fistulae) in more than 95% ofthe cases, and in those cases that require surgery in more than 95%(reduction surgical mortality with use of subject composition).

Also, in medicine the average dosages are determined from a bell-curve.For example, most of the patients might respond to dosages as given.However, the beginning of the bell curve response might be 10% to 50% ofthese dosages and the end of the bell curve might be 125% to 200% ofthese dosages.

In medicine, the average dosages are determined from a bell-curve. Forexample, most of the patients might respond to dosages as given inexample 2 (infant and child). However, the beginning of the bell curveresponse might be 10% to 50% of these dosages and the end of the bellcurve might be 125% to 200% of these dosages.

Example 2

Congenital biliary atresia (CBA) is a rare fatal (prior to treatmentwith this invention) disease without liver transplant, with a U.S.incidence of only 300 cases per year (approximately 1 per 1 million ofU.S. population) with symptoms occurring at onset of infancy thatinclude: poor appetite, poor food intake, extreme jaundice, (21 mgmpercent bilirubin, with biliary obstruction further confirmed by anabnormal dye excretion study. stools were gray, acholic, lacking normalstool bilirubin color), lassitude, weight loss, failure to thrive,abnormal liver function tests, abnormal liver ultrasound, and abnormalbiopsy.

Therapy with the compositions of the invention in a CBA patient usingcomponents No. 1 and No. 2 re-established organ function, stimulatedtissue healing and tissue protein synthesis concurrent with significantanti-inflammatory activity, clearance of all abnormal liver function,and averted the required for a liver transplant.

Components No. 1 and No. 2 were used and the composition comprised of 20to 30 grams L-amino acids and glycine in the molar ratio of breast milksuspended in 4 oz. of water. Four to 6 doses administered daily weresufficient to normalize, over a period of 3 months all abnormal liverfunction studies, abnormal liver ultrasound, abnormal biopsy, as well asreversing symptoms of jaundice, poor appetite, poor food intake,lassitude, weight loss, and failure to thrive, off liver transplantlist. The patient was sent home with happy disposition, not cryingnormal stools, sleeping well and easily burped.

Component No. 3 can also be added in the dosage of 0.5 to 2 grams perday, and optional components No. 4 (¼ to ½ of the dosages asadministered in Example 3b) and component No. 5 can (¼ to ½ the dosageas administered in Example 3b) can also be added to compositions of thesubject invention.

Example 3 Crohn's Disease, (CD) Case Report, Part (a)

A 71 year old female patient with more than 3 decades of Crohn's diseasewhose symptoms included diarrhea, constipation, severe bouts ofabdominal pain and fever, generalized aching, extreme fatigue, nausea,food and dairy intolerance, increased sedimentation rate, recently had aflare up of the Crohn's disease. Response from 4 mgm of corticosteroid,once daily was unsatisfactory. Corticosteroid dosing was then increasedto 4 times daily for acute flare ups.

The patient received a composition comprising 5 to 25 grams of L-aminoacids and glycine, lecithin (phospholipid-PC), and extracellular matrixcomponents comprising collagen, proteoglycan aggregate complex ofcartilage and chondrotin sulfate (shark cartilage 740 mg. per capsule, 4capsules twice daily). Symptoms of severe abdominal pain and diarrhea,and the flare-up were cleared within 24 hours. The improvement continuedover the next few weeks, and the patient responded to the least amountof corticosteroids (alternating daily dosages of a half a tablet (2 mg)with a full tablet (4 mg) required to prevent flare-ups in the pastseveral decades of management.

This reduction in steroid dosage has also reduced severe unsightlybruising and poor healing of lacerations and associated intolerance ofsutures. Her lacerations have been most successfully healed withnon-suture steri strips.

The second therapeutic component comprises 2.1 grams of omega 3 seedoil, (flax oil, sunflower oil, sesame seed oil 1.7 grams of omega 6 oil,and 1 gram omega 9 oil (Flora brand) (with the following well toleratedpreferred recent substitution of omega 3 fish oil and seed oil for justfew weeks: 2 capsules 1-2 times daily, Thera Tears, serving size 2softgels per serving, containing per 2 capsule Vitamin E (as d-alphatocopherol concentrate) 100 IU (anti-rancidity antioxidant), OrganicFlaxseed Oil 500 mg, EPA (Eicosapentaenoic Acid) (from Fish Oil) 225 mg,and DHA (Docosahexaenoic Acid) (from Fish Oil) 50 mg. The anti-rancidityantioxidant vitamin E present in this capsule prevents the developmentof catabolic products that are counter to the components of thistherapeutic innovation accounting for the tolerance of this fish oilproduct.

This patient is one of the unusual patients intolerant to fish oil.Patients with ileitis have a deficiency of pancreatic lipase and entericcoated fish oil capsules may be more helpful in overcoming thisintolerance. This anti-inflammatory immune modulatory pharmacologicactivity is furthered by the addition of vitamin A (5,000 units), 250 mlof vitamin C, 400 ml vitamin E (d alpha tocopherol), selenium (20 mg)and Zinc (15 mg).

It should be noted here that significant progress has been made here andin these foregoing embodiments in masking a major problematic taste ofthe amino acid component which formerly, in the prior art, brought aboutthe requirement of gastric tube administration and associatedhospitalization.

Encapsulation of the medication would eliminate use of the gastric tubeby-passing the problematic taste of the amino acid component. However,for the pediatric or adult patient who can not take capsules, avegetable flavored juice such as, but not limited to, tomato juice or V8could be used as a flavored vehicle. One heaping teaspoon (approximately5 grams) to 5 ounces of juice, was found by a taste panel to thoroughlymask the most objectionable taste of the first component, the amino acidproduct. This amino acid component includes, but is not limited to,Neocate for Infant use. This Crohn's patient was included in our tastepanel in our attempt to improve the palatability of the objectionableamino acid component of subject composition.

Case Report: Example 3, Part (b) Crohn's Disease

Further response to addition of therapeutic components No. 4 and No. 5(All 5 component therapeutic composition response).

Further progress report and addition of components No. 4 and No. 5 tothis patient care added even further to significantly improve herclinical course. The addition of components No. 4 and No. 5 haveprovided for normalization of enzyme composition secretion of the tissueand the normalization of the micro-organism flora with associatednormalization of function of this gastrointestinal Crohn's diseasedtissue has made possible for this patient for the first time to furtherreduce from one tablet of the corticosteroid that this three componenttherapy has permitted to use ½ tablet of corticosteroid (triamcinalonegeneric) for the first time in three decades without usual furthersteroid withdrawal symptoms of arthralgia common in steroid withdrawalas noted repeatedly in this patient in the past unsuccessful attempts ofsteroid reduction.

The side effects this patient has sustained from long-termcorticosteroids has been worsening of osteoporosis documented by twosuccessive bone scans two years apart, recurrent bruising and failure toheal including two threats of the need for skin graft which this subjectcomposition stem cell-like treatment has prevented. Bruising and healingtime of skin trauma as well as GI flare ups of diarrhea greatlyimproved.

Example 4 Countering Wound Healing Impairment with Steroids

The prior embodiments documented the reversal of the need for skin graftin wound treatment of a Crohn's patient (exemplified by adding deficientvitamin A locally to anabolic counter collagenase stimulated bylong-term corticosteroids) along with wound healing when zinc, in theform of zinc oxide, was added to composition No. 5.

Example 5 Orthopedic and Anti-Arthritic Subject Composition Therapy—CaseReport

A female patient age 48 has been treated for acute degenerativearthritis right hip confirmed by x-ray findings. Acute onset, May of O₂associated with progressive pain limping and requirement of support witha cane temporarily relieved by anti-inflammatory drug Vioxx with x-rayfindings of severe inflammatory degenerative arthritis associated withabsence of joint space of right hip joint and clinical regression righthip. Joint prosthetic replacement even though only age 48 wasrecommended by rheumatologist and orthopod. Patient refused surgicalcare and responded with use of extracellular matrix:

ECM: Glucosamine 750 mg. daily, Shark cartilage 450 mg., Cartilage 50mg, gelatin, a denatured collagen, porcine origin, 1 to 2 tablespoons infruit juice.

The addition of an anti-inflammatory immune modulator (omega 3 flax-seedoil, 1000 mg) provided a progressive response with reappearance of thehip joint space on x-ray (severe inflammatory changes had interferedwith visualization of any joint space). Since the patient is nowpain-free and no longer requires a cane supportive of walking, howeverstill had a mild limp, the completion of the synthetic stem cell firstand second component chiral L amino acid and non chiral glycine in themolar ratio of human tissue supportive of the stem cell, along withpolar surface active lipid as phospholipid lecithin was suggested in theform of Neocate progressing from 5 grams daily to 15 grams daily tothree times daily. It is expected that this additional therapy shouldsignificantly add to the therapeutic response progression.

Anti-inflammatory, immune modulatory bio-efficacy, biosafety andpharmacologic activity is present with all four components of syntheticstem cell therapeutic subject composition.

Example 6 Inactivation of Cat Dander Allergen of Cat, to LessenRespiratory Allergy Symptomatology after Cat Exposure (with TherapeuticComponent No. 2)

High HLB liquid crystalline phase semi-conductor bio-computer used hereand its biophysical hydrophilic micellar counterpart with itsanti-allergenic subject composition therapeutic embodiments, in vitrobasophilic de-granulation measure by histamine release comparingefficacy of treated cat dander in preventing histamine release withuntreated cat dander when exposed to serum from cat allergic patients.

Example 7 The Use of High HLB Surfactant in Cancer May be Used Alone oras an Optional Component of Component No. 2

Comparative studies of inactivation of in-vitro cancer using tissueculture techniques with high HLB surfactant, Tween 80 are illustrated inTable 1.

Results of Treating T47D breast cancer tissue cells (Normalized):

TABLE 1 MTS (Breast cancer Mitochondrial activity Assay) % normalizationCulture Time of Breast cancer 24 h 48 h cells Control 1.0 1.0  0%**Tween 80 (0.125%) 0.48 0.24 76% PC (0.125%) 0.92 0.98 Tween 80 + PC0.61 0.42 58% (0.125% + 0.12596) GS-1 (grape seed 0.29 0.17 83% Extract,0.5 mg 1-ml Tween 80 + GS-1 0.27 0.17 83% PC + GS-1 0.34 0.17 83% Breastcancer (Comparative histopathologic studies before and after treatmentwith high HLB Tween 80 surfactant **Histopathologic studies correlatewith a more than 50% reduction of cancer cells seen after 48 hours oftreatment with 0.125% Tween 80.

Summary of Cell Inhibition Assays

Development of metastatic cancer involves several steps, usuallyseparated in to initiating and promotional steps. Initiation involvessomatic mutation leading to altered expression of genes controlling DNAsynthesis and cell replication. Promotion involves stimulation of themutated cell to continued division. Subsequent mutations in thesealtered cells lead to more aggressive replication and invasion ofneighboring tissues. In many tumors, the tumor cells are cycling whiletheir neighbors are in the GO phase of the cell cycle. Substances whichinterfere with mutagenesis or with cell division could prove to beanti-carcinogenic.

Several extracts of these for their abilities to inhibit the metabolismof cells isolated from breast and cervical cancer tissue have beenexamined in regard to the anti-cancer effects of extracts which haveproven capable of significantly inhibiting the metabolism of thesecancer tumor cells. In addition to and equal to the effects of high HLBsurfactants for comparative testing. These comparative studies wereperformed and results are reported in the above table. Metabolism wascomparatively measured with controls and other extracts as to thereduction of mitochondrial activity, (MTS). This compound is a substratefor the mitochondrial enzymes—and is reduced to a blue formazan product.

Activity of the extracts was tested with the MCF-7 and T47-D breastcancer cell lines and against the CaSki and SiHa cervical cell lines.During the later experiments, the CRL 7367 and CRL 7368 cell linesbecame available and were included in subsequent trials. CRL 7368 is aline established from transformed fibroblasts isolated from a breastcancer. CRL 7367 was established from apparently healthy skinfibroblasts taken from the same donor.

Methods

In the first experiments—The extracted therapeutic test agents werederived from specified tissue. Water extracts of the crushed tissue,were also prepared. For the later experiments, specific varieties ofextracts were prepared and examined: Cells were obtained from AmericanType Culture Collection (ATCC, Washington, D.C.) and were cultured asrecommended by ATCC. Experiments were performed in 96 well microtiterplates. Each well contained 1.0×10⁴ cells suspended in a total volume of200 ml. Test wells contained the designated amount of extract in cellculture medium. Control wells contained the same amount of extractsolvent in medium. Plates were incubated in an atmosphere of 5% C0₂ for24 or 48 hours with extract or solvent. At this time, —p1—(MTS) wereadded to each well and incubation was continued for an additional 4hours after which time the optical density (OD) at nm of each well wasrecorded. In each experiment, each sample was assayed in triplicate andthe mean optical density (OD) for the three wells containing the sameculture was calculated.

Results

Data are presented as suppression ratios. The suppression ratio definedhere as the mean optical density (OD) for the wells containing extractdivided by the mean optical density (OD) for the control wells. A valueof this ratio of 1.0 indicates that the extract had no effect onmetabolism of the cells being tested. A value of less than 1.0 indicatesinhibition of cell metabolism by the extract or the high HLB surfactantTween 80.

The purpose of the work was to determine which therapeutic agentextracts (further separated by chromatography) explored through thismethodology for anti-cancer activity. The data presented here representssemi-quantitative anti-cancer screening tests. Extracts with ratios inthe range 0.51-0.74 were considered moderately active and thereforeappropriate for considered use along with preventive anti-cancertreatment and active anti-cancer treatment. In co-use with anti-cancertreatment and radiation treatment, may lessen the dose and the sideeffects of these current therapeutic agents. Extracts with metabolismsuppression ratios less than or equal to 0.5 represented a suppressionof metabolism of at least 50% or greater than that of the controls andwere considered definitely active potential anti-cancer agents, as wasthe case of High HLB Tween 80 with ethylene maturation apoptosispromoting factor with a 76% suppression of mitochondrial metabolism ofcancer cells.

In the first experiments, tissue extract prepared in the laboratory andwater extract from tissue commercially obtained were, comparativelyexamined. These results were presented in Table 1. The data indicatedthat comparatively both therapeutic agents derived from tissue extractsfreshly prepared in this laboratory and water extract inhibit can cellmetabolism at the higher concentrations tested. There is a clear doseeffect indicating that therapeutic agents derived from tissue extractsprepared in our laboratory at concentrations lower than 0.004 andcommercially available water extract concentrations lower than 0.02 donot inhibit metabolism. Data for alcohol extracts were also presented.The extracts had minimal effects on metabolism after three days oftreatment, but after five days of treatment the ethanol extract hadinhibited metabolism of both breast cancer cell lines by over 60%. Someextracts suppressed the MCF-7 cell One, but had minimal effect on theT47-T cell line or on the cervical cancer cell lines even when theextract anti-cancer treatment agent composed 4% of the total culturevolume. Of all the extracts examined the tissue extract anti-cancertreatment agent* obtained with 70% acetone/30% water was the mostactive.

-   -   Acetone is an agent used in separating phospholipid surfactants,        e.g. phosphatidylcholine (PC), phosphatidyl serine (PS),        phosphatidyl inositol (PI), and phosphatidyl ethanolamine (PE)        acetone insoluble representing 58% of surfactants present in soy        lecithin. 70% acetone and 30% water used here as a tissue        extracting agent is most probably an extracted surfactant*.

Example 8 Case Report—Therapeutic Composition to Counter WithdrawalSymptoms and Side Effects of Medications and Drugs and Drug Addictionand Dependency

The Therapeutic Results and Rationale for inclusion of Components No. 4and No. 5: This detailed therapeutic replication of normal human tissue(and therefore complete reversal of disease tissue) and by including theproducts of therapeutic component Nos. 4 and 5, (added to component Nos.1, 2, and 3 past month and added past two months to care of priorpatient), normalization of enzyme composition secretion of the tissueand the normalization of the micro-organism flora with associatednormalization of function of this gastrointestinal Crohn's diseasedtissue has made possible for this patient for the first time (and notreported or taught in that art) to further reduce from one tablet of thecorticosteroid that this three component therapy has permitted to use ½tablet instead of corticosteroid (triamcinalone, common generic) for thefirst time in three decades without usual further steroid withdrawalsymptoms of arthralgia common in steroid withdrawal as noted repeatedlyin this patient in the past unsuccessful attempts of steroid reduction.

The side effects this patient has sustained from long-termcorticosteroids has been worsening of osteoporosis documented by twosuccessive bone scans to years apart, recurrent bruising and failure toheal including two threats of the need for skin graft which this subjectcomposition stem cell-like treatment has prevented. Bruising and healingtime of skin trauma as well as GI flare ups of diarrhea greatlyimproved.

These therapeutic compositions may also be specifically applied toaddiction by mimicking normal tissue metabolism and normal tissueincluding the L-amino acid glycine molar ratio of endorphin tometabolically stimulate and in fact coerce, by the law of mass action,the proteins assemblage system of the body to produce this hormone.Since one mole of tyrosine, two moles of glycine and one mole ofphenylalanine seem to be essential for the narcotic effects of betaendorphin and the met and leu-enkephalins, this anti-addiction effectthen would be compared to the complete L-amino acid glycine molar ratioof beta endorphin. This molar ratio of beta endorphin also includes onemole of methionine, two moles of threonine, two moles of serine, fourmoles of lysine, two additional moles of phenylalanine, one mole ofglutamine, one mold of proline, one mole of valine, one mole of leucine,two moles of asparagine, two moles of alanine, two moles of isoleucine,one mole of tyrosine, one mole of glycine, and one mole of glutamicacid.

The same principles and therapeutic components have been applied innormalizing, as noted in prior embodiments, dependency or withdrawalsymptoms such as, but not limited to, the use of drugs in controlledsubstances, alcohol and/or drug and tobacco addiction in the medicalpatient or veterinary practice or experimental conditions such as theanimal or tissue culture.

Therefore, these therapeutic compositions form a clinical bridge beyondother advanced technologies that have not to date found a clinicalapplication with exemplary bio-safety.

Example 9 Case report—Treatment of E. coli Sepsis

Patient age 77, male, recovered from 10 day hospitalization for surgicalintact removal of gangrenous gallbladder and E. coli sepsis, Apr. 26,2004, responded to a total of 16 days IV Azactam 2 grams and Clindamycin0.9 g, reduced to 0.6 g, q 8 hrs. Balanced B-50 complex, Nature Made,OTC, Mission Hills Calif. 91346-9606.

Ingredients 50 mg of: B-1 Thiamin, B-2 Riboflavin, B-3 Niacin, B-6Pyrdoxin, Pantothenic Acid, Folic Acid 400 mcg, Biotin 50 mcg.

Administered orally (PO), concurrent with IV antibiotics for E. colisepsis (glossitis, magenta inflamed tongue evidence for B-complexassociated with IV antibiotics) prompted the initiation of thismedication and within 1 hour of use profound weakness associated withsepsis and post-op state. These beneficial effects were maintained withthe continued use of balanced B-complex 2×s daily with Centrum OTCmulti-vitamin and mineral compound. This effect correlates with thepre-clinical mouse colony E. coli infected animal studies 90%improvement noted in the Japanese literature March, 2004. This clinicaleffect is novel to the prior art in that it has not been reported in theclinical medical literature to date.

(E.R. admission acute cholecystitis, 20,000 WBC, which increased to30,000 wbc. Surgery not performed for 2.5 days.) IV antibiotics welltolerated.

Common post-op complication of severe weakness and fatigue significantlylessened with balanced B Complex, including 50 mg Riboflavin (magentared tongue prior to this treatment).

PHx of multiple lupoid severe antibiotic vital organ reactions inclusiveof: pericardial infusion due to Biaxin, Penicillin induced nephritis,albuminuria and one occasion frank hematuria. Lupoid hepatitis,Sulfonamides and anti-fungal Miconozole, Drug fever—Quinolones, Flagyland Percocet intolerance.

Local combination of antacid and anesthetic gave prompt relief buthindered acute findings of the disease.

Along with this consideration, nitroglycerin dilated the bile ducts inaddition to the coronary arteries. Also noteworthy, nitroglycerin gaverelief. This clinical correlation with pre-clinical study in mice ishighly significant in that mice have been naturally bred to resistsqualor and E. coli exposure.

Example 10 Case Report Anti-Cancer Therapy Case Report Part a:

A clinical anticancer bi-lamellar surfactant liquid crystal essentialfatty acid emulsion therapeutic study with the additional strategy of“starving” the cancer cell's high carbohydrate based Pet Scan metabolicactivity companion to foregoing surfactant liquid crystal high HLB of 16in vitro anticancer study

A 59 year old male patient was treated for an adenocarcinoma of the leftparotid gland and responded to surgical excision, chemotherapy andradiation.

Five months later within a 1 to 2 cm. radius of prior adenocarcinomatumor a left tonsillar squamous cell carcinoma was detected withmultiple metastasis to bone, lung and brain, with weight loss andcachexia with a very poor prognosis.

Two dosages of chemotherapy were administered. It was noted that anunexpected dramatic clinical response was noted after “supportive”(which proved to be remarkably definitive), essential fatty acid lipid20% non pyrogenic soybean oil emulsion, 4-11% linolenic acid, 44-62%linoleic acid, oleic acid 19-30% stearic acid 1.4%-5% (Intralipid 20%Baxter Healthcare Corporation package insert) and 1.2%” egg yolklecithin phospholipid”, 2.25% hydrophilic glycerine, and H₂O totaling500 ml and 900 K Cal daily for 5 days. PC was used here at 5× surfactantconcentration of ¼% Tween “80. Thereby equilibrating the lower HLB PCwith the high HLB (16) of Tween 80 was successfully used in cancer invitro (prior embodiment).

HLB is a mathematically additive phenomenon. Tween 80 in-vitro studiesreversed and normalized 76% to 83% mitochondrial metabolic activitybreast cancer and 50% of the histopathologic in 24 to 48 hours.

Interpreting this dramatic response in light of the normalization of thecancer tissue with foregoing in vitro studies derived from: (1) asimilar high HL B surfactant effect with cell membrane egg lecithinphospholipid closer to normal cell membrane of a stem cell (fertilizedegg) and (2) closer to mimicking the biochemistry of the stem cell, theprimary inventive mimicking analog directive of this series ofinventions, (3) and in consideration of and based upon the fact that thePET scan is indicative of an aggressive cancer which has significant forcarbohydrate dependent metabolism marker mechanisms.

The use of TV feeding carbohydrate free, hydrophilic surfactant,essential lipid appears to counter the significant PET scan utilizationof Intravenous administration of glucose radioactively tagged in thecancer patient. The glucose dependent cancer cell growth and in a sense“starved” these cancer cells, (a strategy that we were searching for).In addition, this lipid ketogenic IV feeding also turned off insulinproduction, an important molecular stimulus of rapid cell growth anddifferentiation of cancer tissue. Also without the analog requirement ofan electric spark as in a gasoline engine (the opposite of an oil drivendiesel engine) the adverse oxidative metabolic predisposition to cancerand inflammation.

While not wishing to be bound to any theory the in-vitro study high HLBsurfactant and the intrinsic mitochondrial lipid may have been thecoordinated team effect in vitro of normalization of cancer tissue usingthe foregoing rationale mechanism readily adaptable to oncologic care.

Future in vitro and in vivo studies will be carried out on cancer tissueand cancer patients respectively in a similar fashion adding to theforegoing preclinical and clinical trials 0.25 percent of Tween 80 and0.15 percent of sodium lauryl sulfate as well as in further contrast inconjunction with 1.2% PC 20% essential lipid to increase the total highHLB efficacy. These studies will be monitored with PET scan.

Case Report Part b:

To further the anticancer effect of anti-inflammatory therapy of aspirinas observed in bowel cancer (50% efficacy) 25% efficacy in breastcancer;

This therapy aspirin 0.30. g to 0.6 g three x daily anti-inflammatorytherapy is added to 2a to meet any possible future therapeuticresistance.

This anti-inflammatory aspirin therapy is further compared to the use ofanti-inflammatory therapeutic Component No. 2 which includes 2 grams ofomega 3 fish oil 350 mg EPA, 250 mg DHA of total 750 omega 3 fatty acidfish oil with antioxidant of 20 units natural vitamin E (d alphatocopherol) Carlson Arlington Heights, Ill. 60004 and optional inclusionof seed oil, flaxseed oil 250 to 500 mg OTC preferably organic.

High HLB 11 PC 0.9 g American Lecithin, Oxford, Conn. 3× daily

Case Report Part c:

To further advance this anti-cancer effect of therapeutic Component No.2 as modified in 2a, 2b and further modified in 2b with aspirin to bestudied regarding furthering anti-cancer potential by addingsequentially and comparatively Component Nos. 3, 4, and 5. Thesecomparative effects to be studied pre-clinically as a computer model, invitro animal model and finally in clinical applications in cancerpatients, (as a forthcoming NIH planned study to e monitored with a PETscan study.

Note: This anti-cancer anti-inflammatory therapeutic effect in cancercorrelates well with the countless clinical observations that chronicinflammation such as but not limited to ulcerative colitis predisposesto bowel cancer. Asbestosis due to inhalant exposure to asbestos resultsin pulmonary accumulation of non-metabolizable asbestos bodies which hasa cancer inducing incubation period for as long as 20 years withresultant pleural lining cancer of poor prognosis, the mesothelioma.

Example 11 Case Report—Crohn's Disease (CD)

Case Report Part a:

3 component therapeutic subject composition not in prior art

A 71-year-old female patient with more than 3 decades of Crohn's diseasewhose. symptoms included diarrhea, constipation, severe bouts ofabdominal pain and fever, G.I. bleeding generalized aching, extremefatigue, nausea, food and dairy intolerance, increased sedimentationrate, recently had a flare up of the Crohn's disease. Response from 4mgm of corticosteroid, once daily was unsatisfactory. Corticosteroiddosing vas then increased to 4 times daily for acute flare ups. Symptomscleared and permitted 25% decrease in corticosteroid and 80% decrease incorticosteroid that were required for flare ups.

The patient received a composition comprising 5 to 0.25 grams of L-aminoacids and glycine, Neocate infant formula in the genetic code and molarratio of human tissue, (breast milk and stem cell human tissue),lecithin, (phospholipid) P.C. and extracellular matrix componentscomprising collagen, proteoglycan aggregate complex of cartilage andComponent No. 3 chondroitin sulfate (shark cartilage 740 mg. percapsule, 4 capsules twice daily). Symptoms of severe abdominal pain anddiarrhea, and the flare-up were cleared within 24 hours. The improvementcontinued over the next few weeks, and the patient responded to theleast amount of corticosteroids. (alternating daily dosages of a half atablet (2 mg) with a full tablet. (4 mg) required to prevent flare-upsin the past several decades of management.

This reduction in steroid dosage has also reduced severe unsightlybruising and poor healing of lacerations and associated intolerance ofsutures. Her lacerations have been most successfully healed withnon-suture steri strips.

The second therapeutic component comprises 2.1 grams of omega 3 seedoil, (flax oil, sunflower oil, sesame seed oil 1.7 grams of omega 6 oil,and 1 gram omega 9 oil (Flora brand) (with the following well toleratedpreferred recent substitution of omega 3 fish oil and seed oil for justfew weeks: 2 capsules 1-2 times daily, Thera Tears, serving size 2softgels per serving, containing per 2 capsule Vitamin E (as d-alphatocopherol concentrate) 100 IU (anti-rancidity antioxidant), OrganicFlaxseed Oil 500 mg, EPA (Eicosapentaenoic Acid) (from Fish Oil) 225 mg,and DHA (Docosahexaenoic Acid) (from Fish Oil) 50 mg. The anti-rancidityantioxidant vitamin E present in this capsule prevents the developmentof catabolic products that are counter to the components of thistherapeutic innovation accounting for the tolerance of this fish oilproduct.

This patient is one of the unusual patients intolerant to fish oil withthe exception of the foregoing formulation. Patients with ileitis have adeficiency of pancreatic lipase and enteric coated fish oil capsules maybe more helpful in overcoming this intolerance. This anti-inflammatoryimmune modulatory pharmacologic activity is furthered by the addition ofvitamin A (5,000 units), 250 mg of vitamin C, 400 units vitamin E (dalpha tocopherol), Selenium (20 mcg) and Zinc (15 mg).

It should be noted here that significant progress has been made here andin these foregoing embodiments in masking a major problematic taste ofthe amino acid component which formerly, in the prior art, brought aboutthe requirement of gastric tube administration and associatedhospitalization. Also the dose of the L-amino acid glycine, in the molarratio and the genetic code of human tissue formulation, was moderated to5 to 25 g 3× daily.

Encapsulation of the medication would eliminate use of the gastric tubeby-passing the problematic taste of the amino acid component. However,for the pediatric or adult patient who can not take capsules, avegetable flavored juice such as, but not limited to, tomato juice or V8could be used as a flavored vehicle. One heaping teaspoon (approximately5 grams) to 5 ounces of juice, was found by a taste panel to thoroughlymask the most objectionable taste of the first component, the amino acidproduct. This amino acid component includes, but is not limited to,Neocate for Infant use. This Crohn's patient was included in our tastepanel in our attempt to improve the palatability of the objectionableamino acid component of subject composition.

Case Report 3 Part b—Crohn's Disease Therapeutic Composition:

Further response to addition of therapeutic components No. 4 and No. 5(All 5 component therapeutic composition response).

Further progress report and addition of components No. 4 and No. 5 tothis patient care added even further to significantly improve herclinical course. The addition of components 4 and No. 5 have providedfor normalization of enzyme composition secretion of the tissue and thenormalization of the micro-organism flora with associated normalizationof function of this gastrointestinal Crohn's diseased tissue has madepossible for this patient for the first time to further reduce from onetablet of the corticosteroid that this three component therapy haspermitted to use ½ tablet of corticosteroid (triamcinalone generic) forthe first time in three decades without usual further steroid withdrawalsymptoms of arthralgia common in steroid 1 withdrawal as notedrepeatedly in this patient in the past unsuccessful attempts of steroidreduction. With this 5 component therapeutic composition there was a 50%decrease in daily corticosteroid dosage without any flare up of Crohn'sdisease symptoms. A significant corticosteroid sparing effect wasachieved with this 5 component therapy.

Particularly significant in that the side effects this patient hassustained from long-term corticosteroids has been worsening osteoporosisdocumented by two successive bone scans two years apart, recurrentbruising and failure to heal including two threats of the need for skingraft which this subject composition stem cell-like treatment hasprevented bruising and healing time of skin trauma as well as GI flareups of diarrhea greatly improved.

The goal of these series of inventions has been achieved in thenormalization of diseased tissue synergistically with the addition ofgentle bio-safe medical food and medical food (plant and animal) tissuederived as biochemical components.

Each disease group was studied for deficiencies which were corrected asexemplified by component No. 4 and No. 5 to complete the mimicking andanalog structure of normal tissue in the normal replication of humantissue normalizing its structure and function in order to bring aboutthe arrest of the vicious cycle of diseases and their pathogenicmechanisms.

Component No. 4:

The 4th component helps to attain this goal by mimicking and beinganalog to normal human tissue by using these components 1 through 5synergistically, comprises vitamins, minerals, and trace elements.Utilizing documented deficiencies of vitamins, minerals and traceelements from available studies or performing pilot study guide lines.Exemplary deficiencies in Crohn's disease are documented in theembodiments of the examples presented. Vitamins, minerals and traceelements can be provided in various concentrations:

Vitamin B12 (500 micrograms), Nature Made Nutritional Products, MissionHills, Calif., 91348

Centrum Silver which includes: vitamin A (as beta-carotene 5,000 units),vitamin D 400 units, Selenium 20 micrograms, Whitehall-RobinsHealthcare, Madison, N.J. 07940 (see below for complete list ofcontents).

Centrum Silver Supplement Facts Serving Size 1 Tablet % DV Each TabletContains % DV Vitamin A 5000 U Magnesium 100 mg (20% as Beta CaroteneVitamin C 60 mg Zinc 15 mg Vitamin D 400 U Selenium 20 mcg Vitamin E 45U Copper 2 mg Vitamin K 10 mcg Maganese 2 mg Thiamin 1.5 mg Chromium 150mcg Riboflavin 1.7 mg Molybdenum 75 mcg Niacin 20 mg Chloride 72 mgVitamin B₆ 3 mg Potassium 80 mg Folic Acid 400 mcg Boton 150 mcg VitaminB₁₂ 25 mcg Nickel 5 mcg Biotin 30 mcg Silicon 2 mg Pantothenic Acid 10mg Vanadium 10 mcg Calcium 200 mg Lutein 250 mcg Phosphorus 48 mg Iodine150 mg Balanced B 50 Complex, containing Thiamin (50 mg), Riboflavin (50mg), Niacin (50 mg), Vitamin B6 (50 mg), Folic Acid (400 mcg), VitaminB12 (50 mcg), Biotin (50 mcg), Panthothanic Acid (50 mg.), Nature MadeNutritional Products, Mission Hills, CA, 91348 Vitamin C, (500 mg,)Timed release capsules. J. R. Carlson Lab. Inc., Arlington Heights, IL60004 Vitamin E, (400 units). D alpha tocopherol, J. R. Carlson Lab.Inc., Arlington Hts. IL 60004

Component No. 5:

An extension of treatment of the synthetic stem cell therapy subjectcomposition in the same patient as Ex. 1 with the addition of componentNo. 4 presented in detail in Ser. No. 09/639,859 and therapeuticcomponent No. 5 enzyme and pro-biotic 0.9 g tablets two tablets daily tothree times a day preferably before meals of enzyme replacement andpro-biotic microflora normalizing factor that comprises Phytozyme,#6122, (Life Plus Int'l. Batesville, Ark.), Amylase (50 mg), Bile (45mg), Bromelain (30 mg), Lipase (25 mg), Pancreatin 6× (NF) (100 mg),Pancrelipase (110 mg), Papain (30 mg), Pepsin (70 mg), Betaine HCl (100mg), and Probiolic Blend (20 mg) tablet, dosage 2 tablets 2 to 3× dailyhaving the ingredients: Betaine, HCl, Pancrelipase, Pancreatin 6× (NF),Pepsin, Dicalcium Phosphate, Amylase, Bile, Bromelain, Papain, Lipase,L-Glutaminic Acid, (ProBio Tx), Stabilized Probiotic Blend (each dosage:200,000,000 probiotic microflora including Lactobacillus acidophilusDDS-1, Bifido-bacterium bifidum, Lactobacillus bulgaricus, Lactobacillussalivarius), vegetable and fruit concentrates. Deficiencies ofpancreatic enzymes are readily available in exampled disease, Crohn'sdisease, along with cystic fibrosis. Therefore corrected here in thetherapeutic component formulations to normalize not only human tissuebut its secretions. Reversal to normal flora with probiotic also readilyavailable and, therefore, used here for the same therapeutic rationaleof normalization of tissue, its symbiotic surface bacteria andassociated secretion contents of enzymes.

In the case of the gastrointestinal tract in diseases such as, but notlimited to, Crohn's disease, the addition of enzymatic therapy ofcomponent No. 5 and the addition of pancreatic and enzymatic replacementof deficiencies present herein normalizes the gastrointestinal secretioncomponent and byproduct of human tissue. The addition of pro-bioticmicroorganism therapy such as, but not limited to, Saccharomycesboulardii helps normalize the abnormal microflora that the diseasegastrointestinal tract such as but not limited to Crohn's diseasepredisposes to thereby even further normalizing abnormal microflora(which this vicious cycle chronic granulomatous Crohn's disease hasfostered) the gastrointestinal microflora, tissues and secretions.

This detailed therapeutic replication of normal human tissue secretions,deficient in such diseases as Crohn's disease and cystic fibrosis, (andtherefore synergizes further complete reversal of disease tissue). Byincluding therapeutic component Nos. 4 and 5 and secretions of thetissue and the normalization of the micro-organism flora with associatednormalization of function of this gastrointestinal Crohn's diseasedtissue has made possible for this patient for the first time to furtherreduce from one tablet of the corticosteroid that this three componenttherapy has permitted to use ½ tablet instead (Triamcinalone, generic)for the first time in three decades. The side effects this patient hassustained from long-term corticosteroids has been worsening ofosteoporosis documented by two successive bone scans two years apart,recurrent bruising and failure to heal including two threats of the needfor skin graft which this subject composition stem cell-like treatmenthas prevented.

These favorable conditions make it more and more difficult for thediseased tissue, such as but not limited to chronic granulomatousdisease, as in Crohn's disease and thereby reversing the vicious cycleof this disease and other diseases such as but not limited to Crohn'sdisease. This has proved itself clinically in the embodiment examplecited here wherein digestive enzyme formulation containing pancreaticenzyme replacement, (as well to as bile which has also been incriminatedas deficient in Crohn's disease) along with pro-biotic micro-organismresulted in flora normalization. The pro-biotic in this case wasLactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillusbulgaricus, Lactobacillus salivarius use of in this addition andcompletion of the normalization therapeutic stem cell-like repair kitformulation.

Most importantly component steps are analogous to a team or corporateapproach to the normalization of tissue with anabolic reconstructivereversal of the pathogenesis of a complex vicious cycled catabolicdestructive disease further analog to the underlying pathogeneticmechanisms and the basis of the former refractory state of disease.Crohn's disease and many other diseases with such analogous pathogeneticdestructive componential mechanisms, associated deficiencies andmedication side effects can be treated with the subject composition.Preferably to best address this disease state, all components ofsynthetic stem cell like subject composition formulations are containedin the molar ratios of human tissue.

Conclusion: Through the use of medical food derived synergisticcomponents, drug usage with significant side effects have beensignificantly spared. Such high risk drugs as corticosteriods in Example#3 have been greatly minimized in successful Crohn's Disease management.This goal of eliminating the side effects of 3 decades of systemiccorticosteroids is being furthered by the addition of Entocort(budesonide), a primarily a gastrointestinal surface actingcorticosteroid whereby 1 to 2 dosages, 3 mgm capsule of Entocort EC willbe used daily to further attempt the complete discontinuance of highrisk systemic corticosteroids.

Drug efficacy has been maximized and their side effects minimized as inanti-sepsis therapy and as in the anti-cancer therapy discussed supra.

Each disease group was studied for deficiencies which were corrected asexemplified by components No. 4 and No. 5 to complete the mimicking andanalog structure of normal tissue in the normal replication of humantissue normalizing its structure and function in order to bring aboutthe arrest of the vicious cycle of diseases and their pathogenicmechanisms.

The goal of these series of inventions has been achieved in thenormalization of diseased tissue synergistically with the addition ofgentle bio-safe medical food and medical food (plant and animal) tissuederived as biochemical components.

Example 12 Case Report Treatment of Gout

Another case example of a gentle, side effect free, economic drugdiscovery derived from this new drug discovery technology and newperiodic table. A patient is being treated for gout. Patient isintolerant to cyclo-oxygenase Cox 1 anti-inflammatory drugs such as ASAeven in small dosages. Intolerant that side effects of severe fatigueinterfere with daily activity. The patient was also found to beintolerant to Cox 2 inhibitor Bextra 20 mgm unanticipated side effectswas pyrosis of almost 1 weeks duration whereas the antioxidant ascorbicacid as 8 grams 16 capsules'/gram each of time release ascorbic acidgranules (Carlson Lab, Arlington Heights, Ill.). The time releasedgranules was used avoid similar upper GI symptoms (family history of ableeding ulcer) this 8 gram course of ascorbic acid was repeated once ortwice in 4-8 hrs was associated with complete relief of acute and severegouty arthritis symptoms (uric acid blood levels of 8-10 g %). Suchlarge dosages of ascorbic acid have been repeatedly reported asharmless.

Thereby this new drug discovery therapeutics for gout was again storedfrom medical foods and proves to be bio-safe, free of side effects andeconomically derived. This is in sharp contrast to such highly effectivebut high risk medications such as Allopurinol with such severe sideeffects that include a mortality risk. This risk is particularlypertinent in patients such as case#1 with multiple severe drug reactionsthat threaten vital organs such false lupus drug reactions.

Uric acid is an anti-oxidant that is replaced by the innocuousantioxidant ascorbic acid.

The anti-oxidant ascorbic acid can be synthesized by the animal kingdomwhere as the anti-oxidant in uric acid is not present in animals helpfulcomparative biology in drug development.

Example 13 The Protective Use of Liquid Crystal Subject CompositionMedication Therapy in Nuclear Radiation Treatment of Cancer

Tissue protection against nuclear radiation, such as used in oncology orinadvertent nuclear radiation accidents or bioterrorism. It has beenobserved in approximately 100 controlled animal studies that the tissueshave been protected by specifically, but not limited to, component No.1, NH₂ and SH moieties.

Example 14 Direct Anti-Inflammatory Effect of Liquid Crystal on InflamedIleum, Obtained by Biopsy, and In Vitro Chemokine Tissue Studies

Results showed reduced production of the pro-inflammatory cytokine IL-1Bin ileitis, obtained by biopsy, by more than 80% in 24 hours ofmedication exposure. This reduction was significantly greater than thatobserved in normal intestinal tissue. The mean reduction of IL-1B 1248pg/g compared with a mean reduction in a normal intestinal tissue sampleof 200 pg/g.

Example 15 Bio-Terrorism Vaccine Protection Utilizing Oral MucosalDelivery of Vaccine

In the experimental animal, oral mucosal delivery of vaccine wasperformed and found to produce equal antibody protection as vaccineadministered by injection. Further patented and patent pendingtechnology, including liquid crystal processing to remove allergenic anduntoward pathogenic factors while increasing immunogenicity.

Example 16 Treatment of Tonsillar Cancer Anal, Cancer and Small CellLung Cancer

At the time of treatment, Patient 1 was an approximately 35 year oldmale diagnosed with tonsillar cancer. His prognosis was determined to bepoor. At the time of treatment, Patient 2 was an 81 year old malediagnosed with anal cancer having local dissemination. At the time oftreatment, Patient 3 was an approximately 70 year old female diagnosedwith intractable small cell lung cancer, with metastasis and cachexia.Patient 3 weighed approximately 90 lbs and complained of fatigue.

Patient 2 received a sterile non-pyrogenic composition of about 20%essential fatty acids (a mixture of linoleic and linolenic acid), 1.2%egg yolk phospholipid, and about 2% glycerin in water for injection.This composition is sold commercially as “Intralipid,” and was obtainedfrom Baxter Healthcare Corp. (Deerfield, Ill.). Intralipid ismanufactured for Baxter Healthcare by Fresenius Kabi AB (Uppsala,Sweden). Five hundred milliliters of Intralipid was given intravenouslythree times a week for one week. Patients 1 and 3 received a similarcomposition called Liposyn (Abbot Laboratories) intravenously threetimes a week for one week. Patient 2 received 500 ml per dose andPatient 3 was administered only 250 ml per dose. Liposyn is a sterile,nonpyrogenic fat emulsion for intravenous administration, which containsabout 10% safflower oil, 1.2% egg phosphatides and about 2.5% glycerinin water for injection.

Patients 1-3 showed an improvement in overall health, including anincrease in energy and relief of the fatigue and listlessnesscharacteristic of cancer and disseminated cancer. Clinical signs ofdisease were visibly lessened. Regarding Patient 1, the prognosis was sograve that any signs of recovery were unexpected. However, after oneweek of treatment, it was reported that the improvement in Patient 1 wasso dramatic that health-care personnel had to verify the patient's nameto be sure he was the same patient that had been admitted. Patient's 1improvement continued throughout the entire course of treatment. Patient2 was observed walking down the hall one month after treatment, and hisgait was remarkably brisk in view of his age, and the extent andlocation of his anal cancer. Patient 3 suffered from the fatiguecharacteristic of cancer, particularly when complicated by metastasisand cachexia. However, 24 hours after administering the composition toPatient 3, her fatigue completely resolved, which was a completelyunexpected result in a patient with such a poor prognosis. This completeclearance of fatigue was noted again, lasting for 24 hours, afteradministration of the next two doses.

Example 17 Treatment of Squamous Cell Cancer, Lung Adenocarcinoma,Metastatic Lung Cancer and Anal Cancer

Patient 4 is a 57-year old male with squamous cell cancer of thehypopharynx. Within one week, this patient was given a single dose of500 ml Intralipid (20%) and a single dose of 500 ml Intralipid (10%).After this treatment, the patient showed some clinical improvement inenergy levels and a decrease in lassitude.

Patient 5 is a 74-year old female with adenocarcinoma of the lung. Thispatient received three 500 ml doses of Intralipid (20%) in one week, andshowed moderately increased energy levels and a reduction in lassitude.

Patient 6 is an 81-year old male suffering from right upper lobe lungcancer with metastatic spread in cervical lymph nodes right to left.This patient received one-daily doses of 250 ml Intralipid (10%) for 3consecutive days. Patient 6 showed marked improvement in energy levelsand a more than 60% lessening of radiation treatment side effects.

Patient 7 is an adult male, 82-years old, suffering from anal cancercomplicated by severe cachexia. At the time of treatment, this patientweighed approximately 144 lbs. Upon 3 times weekly dosing with 500 mlIntralipid (20%), the size of a superficial tumor in the anal/perianalarea (initially 5 cm) was reduced 40% in size after three days oftreatment. After five treatments, the enlarged inguinal lymph nodesreturned to normal. One indication that local dissemination of thecancer had improved.

From clinical observations of these patients before, during and aftertreatment with the Intralipid and Liposyn compositions, it is believedthat the improvement in their clinical condition was the direct resultof administering the composition.

Example 18-Treatment of Crohn's Disease

A 73 year old female patient suffering from Crohn's disease (symptomsincluded diarrhea, constipation, severe bouts of abdominal pain andfever, G.I. bleeding, generalized aching, extreme fatigue, nausea, andfood and dairy intolerance) was being treated with corticosteroidsadministered three times weekly. This patient was administered acomposition comprising about 10.6 g Neocate infant formula containingL-amino acids and glycine; about 50-100 mg lecithin; about 12.5-40 mgphosphatidyl choline; about 1000 mg fish oil concentrate (Entero-coatedFish Oil, 180 mg EPA and 120 mg DHA, Leiner Health Products, LLC, CarsonCalif.); VSL (Biffidum bacterium breve, Lactobacillus acidophilus, B.bacterium longum, L. plantarum, B. bacterium infantis, L. baracaciae,Streptococcus thermophilus, L. bulgaricus) and/or Digestive Formulatwo-phase digestive aid available from Life Plus International,Batesville, Ak. (1 tablet daily, contains pancreatin, pancreolipase,pepsin, amylase, papain, bromelain and lipase, betaine, lactobacillusmicroflora such as L. salivarius, L. acidophilus, L. dds-1, L.bulgaricus and Biffidum bacteria, bile, lecithin, peppermint leaf, aloevera and beetroot), extracellular matrix components comprising collagen,proteoglycan aggregate complex of cartilage and chondroitin sulfate(bovine and/or shark cartilage, four 740 mg capsules, twice or moredaily), 3 mg boron, microcrystalline hydroxyapaptite (4762 mcg suppliedas “Boneup” from Jarrow Formulas, Los Angeles, Calif., of which 1000 mcgis Ca, 510 mcg is P, and 1514 mcg is protein, 500 mg magnesium oxide, 10mg zinc monomethionate, 1 mg copper gluconate, 1 mg manganese citrate,300 mg glucosamine, 200 mg Vitamin C, 500 IU of Vitamin D3, 100 mcgVitamin K as menaquinone-7, 400 mcg folic acid, and 100 mcg VitaminB12), 200 mcg selenium, an additional 500-1000 mcg Vitamin B12, and 5 ml(preferably at bedtime) daily to three times a week of cherry flavoredpotassium chloride oral solution U.S.P. 10% (HUMCO, Texarkana, Tex.75501), which contains 20 mEq (1.5 g) of potassium chloride. At times,the patient was given the potassium chloride solution as much as 5 mlthree times a day as much 15 ml two to three times a day. Clinicalobservation showed an amelioration of severe abdominal pain anddiarrhea, a decrease in fatigue, and control of osteoporosis caused bysteroid use, age and previous ovarectomy. Complete normality ofsedimentation rate and C-reactive proteins was also observed. A recentmild myocardial infarction has prompted the addition of three 900 mgarginine capsules in addition to the above-listed components which,along with nitroglycerin patches, has served to reduce angina. A goiterpresent in the patient's neck has also been maintained at a manageablesize, which has precluded the need for surgical removal of the goiter.It should be noted that, at time, the VSL is not swallowed, but onlyused as a mouth rinse because it can aggravate the patient's diarrhea.While the present invention has been described in connection with thedescribed embodiments, it is understood that other similar embodimentsmay be used or modifications and additions made to the describedembodiments for performing the same function without derivatingtherefrom. Therefore, the invention should not be limited to any singleembodiment, but rather should be construed in breadth and scope inaccordance with the recitation of the appended claims.

The following applications are hereby incorporated by reference in theirentireties, including all figures, formulae, references, amino acid andnucleic acid sequences, and tables: Ser. No. 10/765,664, filed Jan. 26,2004; 60/442,278, filed Jan. 24, 2003; 60/447,779, filed Feb. 13, 2003;60/448,003, filed Feb. 18, 2003; 60/448,497, filed Feb. 19, 2003;60/478,565, filed Jun. 12, 2003; 60/493,237, filed Aug. 6, 2003;60/523,936, filed Nov. 21, 2003; Ser. No. 10/752,298, filed Jan. 5,2004; 60/437,939, filed Jan. 3, 2003; Ser. No. 10/269,613, filed Oct.11, 2002; 60/358,890, filed Feb. 22, 2002; 60/350,119, filed Nov. 9,2001; Ser. No. 09/611,857, filed Jul. 7, 2000; Ser. No. 09/781,586,filed Feb. 9, 2001; Ser. No. 09/639,859, filed Aug. 16, 2000; Ser. No.09/731,608, filed Dec. 7, 2000; 60/149,338, filed Aug. 17, 1999; U.S.Provisional Patent Application Ser. Nos. 60/577,120; filed Jun. 4, 2004,entitled “Pharmacology and Pharmacodynamic Rationale Sourcing of Q101 KCfor Crohn's Disease and Pediatric Crohn's Disease”, Leonard Girsh(Inventor) and having Attorney Docket # GIR-109P; 60/557,584; filed Mar.29, 2004 (GIR-105CXCZ1); 60/550,797, filed Mar. 5, 2004 (GIR-105CXC2P);and 60/478,565, filed Jun. 12, 2004 (Attorney Docket # GIR-106P).

REFERENCES

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1. An composition comprising: a) at least one glycosaminoglycan,proteoglycan aggregate complex of hyaluronic acid, extracellular matrix,protein and chondroitin, extracellular matrix compound in an amounteffective in the damaged tissue as an anti-neo-inflammatory andanti-neo-angiogenetic agent; b) about one to three grams of at least onepolar surface active lipid selected from the group consisting ofphosphatidic acid, phophatidylethanolamine, lecithin,phosphatidylserine, phosphatidylinositol, 2-lysolecithin, plamalogen,choline plasmalogen, phostidyiglycerol, diphosphatidylglycerol,sphingomyelin, and any combination of 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11of said polar active surface lipids; c) a plurality of enantiomericallypure L-amino acids and glycine of about 9 to 25 grams in molar ratios ofhuman tissue; d) a component selected from the group consisting ofPolyoxyethylene Sorbitan Monooleate (TWEEN 80), Sorbitan monooleate(SPAN 80), grape seed extract, grape extract, and combinations thereof;and e) vitamins, minerals or trace elements selected from the groupconsisting of Vitamin B12, Vitamin E, selenium, zinc, and combinationsthereof.
 2. The composition of claim 1, further comprising one or morecompound(s) generally accepted as safe (GRAS) selected from the groupconsisting of aspartame perfluorocarbon resins, perfluorocarbon curedelastomers, [alpha]-Amylase enzyme preparation from Bacillusstearothermophilus, benzoic acid, bromelain, catalase (bovine liver),lactic acid, linoleic acid, potassium acid tartrate, propionic acid,stearic acid, tartaric acid, diacetyl tartaric acid esters of mono- anddiglycerides, ammonium bicarbonate, ammonium carbonate, ammoniumchloride, ammonium hydroxide, ammonium citrate, dibasic, ammoniumphosphate, monobasic; ammonium phosphate, dibasic; bacterially-derivedcarbohydrase enzyme preparation; bacterially-derived protease enzymepreparation; bentonite; benzoyl peroxide; n-Butane and iso-butane;Calcium glycerophosphate; Calcium lactate; Calcium pantothenate; Calciumpropionate; Calcium stearate; Carbon dioxide; Beta-carotene; Cellulaseenzyme preparation derived from Trichoderma longibrachiatum; Clove andits derivatives; Cocoa butter substitute; Copper gluconate; Coppersulfate; L-Cysteine; L-Cysteine monohydrochloride; Dextrin; Diacetyl;Enzyme-modified fats; Ethyl alcohol; Ficin; Glucono delta-lactone; Corngluten; Wheat gluten; Glyceryl monooleate; Glyceryl behenate; Glycerylpalmitostearate; Helium; Inositol; Insoluble glucose isomerase enzymepreparations; Isopropyl citrate; Animal lipase; Magnesium carbonate;Magnesium chloride; Magnesium hydroxide; Magnesium oxide; Magnesiumphosphate; Magnesium stearate; Magnesium sulfate; Malt; Malt syrup (maltextract); Manganese chloride; Manganese citrate; Manganese gluconate;Manganese sulfate; Microparticulated protein product; Mono- anddiglycerides; Monosodium phosphate derivatives of mono- anddiglycerides; Niacin; Niacinamide; Nickel; Nitrogen; Nitrous oxide;Peptones; Pancreatin; Papain; Pectins; Pepsin; Potassium bicarbonate;Potassium carbonate; Potassium chloride; Potassium hydroxide; Potassiumlactate; Propane; Pyridoxine hydrochloride; Rennet (animal-derived) andchymosin preparation (fernentation-derived); Riboflavin;Riboflavin-5′-phosphate (sodium); Sodium benzoate; Sodium carbonate;Sodium hydroxide; Sodium hypophosphite; Sodium lactate; Sodiummetasilicate; Sodium propionate; Sodium sesquicarbonate; Sodiumtartrate; Sodium potassium tartrate; Starter distillate; Stearylcitrate; Thiamine hydrochloride; Thiamine mononitrate;[alpha]-Tocopherols; Triacetin; Tributyrin; Triethyl citrate; Trypsin;Urease enzyme preparation from Lactobacillus fermentum; Vitamin A;Vitamin B12; Candelilla wax; Carnauba wax; Bakers yeast extract; Zein;Sulfamic acid; Clay (kaolin); Ferric oxide; Iron oxides; Japan wax; Talloil: Alfalfa; Allspice; Almond, bitter (free from prussic acid);Ambrette; Angelica root; Angelica seed or stem; Angostura; Anise;Asafetida; Balm; Balsam of Peru; Basil; Bay leaves; Bay; Bergamot(bergamot orange); Bois de rose; Cacao; Camomile (chamomile); Capsicum;Caraway; Cardamom seed (cardamon); Carob bean; Carrot; Cascarilla bark;Cassia bark, Chinese; Cassia bark. Padang or Batavia; Cassia bark,Saigon; Celery seed; Cherry, wild, bark; Chervil; Chicory; Cinnamonbark, Ceylon; Cinnamon bark, Chinese; Cinnamon bark, Saigon; Cinnamonleaf, Ceylon; Cinnamon leaf. Chinese; Cinnamon leaf, Saigon; Citronella;Citrus peels; Clary (clary sage); Clove bud; Clove leaf; Clove stem;Clover; Coca; Coffee; Cola nut; Coriander; Corn silk; Cumin (cummin);Curacao orange peel; Cusparia bark; Dandelion; Dandelion root; Dill; Doggrass (quackgrass, triticum); Elder flowers; Estragole; Estragon(tarragon); Fennel, sweet; Fenugreek; Galanga (galangal); Garlic;Geranium; Geranium, East IndianGeranium, rose; Ginger; Glycyrrhiza;Glycyrrhizin, ammoniated; Grapefruit; Guava; Hickory bark; Horehound(hoarbound); Hops; Horsemint; Hyssop; Immortelle; Jasmine; Juniper(berries); Kola nut; Laurel berries; Laurel leaves; Lavender; Lavender,spike; Lavandin; Lemon; Lemon balm (see balm).; Lemon grass; Lemon peel;Licorice; Lime; Linden flowers; Locust beanLupulin; Mace; Malt(extract); Mandarin; Marjoram, sweet; Mate 1; Menthol; Menthyl acetate;Molasses (extract); Mustard; Naringin; Neroli, bigarade; Nutmeg; Onion;Orange, bitter, flowers; Orange, bitter, peel; Orange leaf; Orange,sweet; Orange, sweet, flowers; Orange, sweet, peel; Origanum; Palmarosa;Paprika; Parsley; Pepper, black; Pepper, white; PeppermintPeruvianbalsam; Petitgrain; Petitgrain lemon; Petitgrain mandarin or tangerine;Pimenta; Pimenta leaf; Pipsissewa leaves; Pomegranate; Prickly ash bark;Rose absolute; Rosa; Rose; Rose buds; Rose flowers; Rose fruit (hips);Rose geranium; Rose leaves; Rosemary; Rue; Saffron; Sage; St. John'sbread; Savory, summer; Savory, winter; Schinus molle; Sloe berries;Spearmint; Spike lavender; Tamarind; Tangerine; Tannic acid; Tarragon;Tea; Thyme; Triticum; Tuberose; Turmeric; Vanilla; Violet flowers;Violet leaves; Violet leaves absolute; Wild cherry bark; Ylang-ylang;and; Zedoary bark, or any combination of said compounds.
 3. Thecomposition of claim 1, further comprising a flavorant.
 4. Thecomposition of claim 3, wherein said flavorant is a fruit juice.
 5. Thecomposition of claim 4, wherein said fruit juice is tomato juice.
 6. Thecomposition of claim 1, wherein said amino acids are L-Leucine,L-Proline, L-Arginine, L-Valine, L-Aspartic Acid, L-Isoleucine, Glycine,L-Threonine, L-Tyrosine, L-Phenylalanine, L-Serine, L-Histidine,L-Alanine, L-Cystine, L-Tryptophan, L-Methionine, L-Glutamine,L-Glutamic Acid. L-Taurine, and L-Carnitine.
 7. The composition of claim1, wherein said component (c) comprises Corn Syrup Solids, High OleicSafflower Oil, Refined Vegetable Oil, L-Lysine L-Glutamate, CalciumPhosphate Dibasic, and less than 2% (by weight) of each of thefollowing: L-Leucine, Tripotassium Citrate, L-Proline, L-Arginine,L-Valine, L-Aspartic Acid, L-Isoleucine, Glycine, L-Threonine,L-Tyrosine, L-Phenylalanine, L-Serine, L-Histidine, L-Alanine, Mono andDiglycerides, Sodium Chloride, L-Cystine, L-Tryptophan, MagnesiumAcetate, L-Methionine, Potassium Chloride, Diacetyl Tartaric Acid Estersof Monoglycerides, L-Glutamine, Choline Bitartrate, L-Glutamic Acid,M-Inositol, L-Ascorbic Acid, Soy Lecithin, Tricalcium Phosphate, FerrousSulfate, Zinc Sulfate, L-Carnitine, Niacinamide, DL-alpha TocopherylAcetate, Calcium D-Pantothenate, Cupric Sulfate, Manganese Sulfate,Pyridoxine Hydrochloride, Vitamin A Acetate, Riboflavin, ThiamineChloride Hydrochloride, Potassium Iodide, Chromium Sulfate,Phylloquinone, Sodium Molybdate, Folic Acid, Sodium Hydrogen Selenite,D-Biotin, Vitamin D₃ and Cyanocobalamin.
 8. The composition of claim 7,wherein said composition further comprises taurine.
 9. A method oftreating Crohn's disease comprising the administration of a compositionaccording to claim 1 to an individual in an amount sufficient toalleviate symptoms associated with Crohn's disease.
 10. A method ofreducing the amount of corticosteroid necessary for the treatment ofCrohn's disease in an individual having Crohn's disease comprising theadministration of a composition according to claim 1 to said individualin an amount sufficient to reduce the amount of corticosteroid necessaryto control the disease.
 11. An anabolic composition, comprising at leastone amino acid, at least one extracellular matrix compound, and at leastone surfactant, wherein the concentration of surfactant in thecomposition is about 1% or greater (w/w or w/v) with respect to thetotal composition.
 12. The anabolic composition of claim 11, wherein theat least one surfactant is a lipid.
 13. The anabolic composition ofclaim 12, wherein the lipid is a phospholipid or essential lipid. 14.The anabolic composition of claim 13, wherein the lipid is selected fromthe group consisting of phosphatidylcholine; phosphatidylserine;phosphatidylinositol; phosphatidylethanolamine; phosphatidic acid;phosphatidyl glycerol sphingolipids; sphingomyelin; glycolipids;cerbrosides; gangliosides; cephalin; lipovitellin; glycosphingolipids;lipids containing linoleic or linolenic acids; EPA; DHA and combinationsthereof.
 15. The anabolic composition of claim 1, wherein the at leastone surfactant is selected from the group consisting of glycerolmonostearate; diethylene glycol fatty acid ester; polyoxyethylenesorbitol beeswax derivative; diethylene glycol monolaurate; diethyleneglycol fatty acid ester; polyoxyethylene dioleate; sorbitanmonopalmitate; sorbitan monolaurate; tetraethylene glycol monostearate;tetraethylene glycol monooleate; polyoxypropylene mannitol dioleate;polyoxyethylene sorbitol lanolin oleate derivative; polyoxypropylenestearate; polyoxyethylene fatty acid; polyoxyethylene sorbitol beeswaxderivative; polyoxyethylene sorbitan monostearate; polyoxyethylenesorbitan monooleate; polyoxyethylene oxypropylene oleate;polyoxyethylene cetyl ether; polyoxyethylene sorbitan tristearate;polyoxyethylene lauryl ether; tetraethylene glycol monolaurate;polyoxyethylene lauryl ether; polyoxyethylene sorbitan trioleate;hexaethylene glycol monostearate; polyoxyethylene esters of mixed fattyand resin acids; polyoxyethylene oxypropylene oleate; polyoxyethylenelanolin derivative; polyoxyethylene monostearate; polyoxyethylenemonopalmitate; alkyl aryl sultanate; triethanolamine oleate;polyoxyethylene alkyl phenol; polyoxyethylene sorbitol lanolinderivative; polyoxyethylene alkyl aryl ether; polyoxyethylene castoroil; polyoxyethylene vegetable oil; polyoxyethylene oleyl ether;polyoxyethylene stearyl alcohol; polyoxyethylene oleyl alcohol;polyoxyethylene fatty alcohol; polyoxyethylene cetyl alcohol;polyoxyethylene glycol monopalmitate; polyoxyethylene sorbitanmonopalmitate; polyoxyethylene oxypropylene stearate; sodium oleate;potassium oleate; N-cetyl-N-ethyl morpholinium; polyglycerolpolyricinolate; polysorbate 80; polysorbate 65 and sodium laurylsulfate.
 16. The anabolic composition of claim 11, wherein the at leastone surfactant is selected from the group consisting of lipid, aphospholipid, a glycolipid, a monoglyceride, a diglyceride and alipoprotein.
 17. The anabolic composition of claim 11, wherein the atleast one surfactant is present in a concentration of between about 1.2%and about 20%.
 18. The anabolic composition of claim 11, wherein the atleast one surfactant is present in a concentration selected from thegroup consisting of about 1.2%, about 1.3%, about 1.4%, about 1.5%,about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 3%,about 4%, about 5%, about 10% and about 15%.
 19. The anaboliccomposition of claim 11, wherein the extracellular matrix compound isselected from the group consisting of glucosamines, glycosaminoglycans,collagens, cartilage, chondroitin sulfates, hyaluronic acid, hyaluronanmucopolysccharides, glycoproteins, and proteoglycans.
 20. The anaboliccomposition of claim 11, further comprising at least one electrolyte,mineral, vitamin, trace element, or combinations thereof.
 21. Theanabolic composition of claim 11, further comprising a probiotic.
 22. Amethod of treating a disease or condition in a subject, comprising: (1)providing a subject who has the disease or condition; (2) administeringto the subject an effective amount of a composition comprising at leastone surfactant, wherein the total concentration of surfactant in thecomposition is greater than 1% (w/w or w/v).